Controlled localities — what they are and why they matter
How controlled locality determinations affect pharmacy applications and dispensing doctor arrangements in rural England.
What is a controlled locality?
A controlled locality is an area that has been formally determined to be 'essentially rural in character' under the NHS Regulations. The determination is made by the ICB. Controlled localities are typically rural or semi-rural areas where the population is dispersed and access to pharmaceutical services is more limited than in urban settings.
Why controlled localities matter
Different rules apply to pharmacy applications made in controlled localities. In particular, the Regulations include specific provisions about the granting of new contracts, the notification of existing contractors and the interaction between pharmacies and dispensing doctors in rural areas. Failing to recognise that a proposed site is within a controlled locality — or failing to account for its implications — is a common error in poorly prepared applications.
Dispensing doctors
In controlled localities, general practitioners may have the right to dispense medicines to their patients — known as dispensing doctors. The existence of dispensing doctors in an area affects both the market entry process and the commercial viability of a proposed new pharmacy. Applications in controlled localities must be assessed against the dispensing doctor landscape as well as existing pharmacy provision.
Rurality matters in Wales
Similar provisions exist under the Welsh pharmaceutical regulations, where local health boards make rurality determinations for their areas. The details differ from the English framework and specialist advice on Welsh applications in rural areas is important.
Frequently asked questions
A controlled locality determination is made by the ICB for the relevant area. The ICB assesses whether the area is essentially rural in character, taking into account factors including population density, settlement patterns and the nature of the local environment. Once an area is determined to be a controlled locality, different rules apply to pharmacy applications made within it.
In a controlled locality, a pharmacy application must pass an additional test — the controlled locality test — before the standard market entry criteria are considered. This test assesses whether the granting of a new pharmacy would prejudice the proper provision of pharmaceutical services in the locality, taking into account the presence of dispensing doctors. Failing this test means the application cannot proceed, regardless of whether there is a pharmaceutical need.
Within a controlled locality, certain locations may be designated as reserved locations — areas where a pharmacy cannot be granted because doing so would undermine the dispensing doctor arrangements in that area. Reserved location determinations are made by the ICB and can be challenged in certain circumstances. TI Pharmacy Consultancy advises on reserved location issues before any application in a controlled locality is submitted.
Yes. Controlled locality determinations can be reviewed if the character of an area changes over time — for example, due to significant new housing development. Applications to change a controlled locality determination are a specialist area. TI Pharmacy Consultancy advises on whether a change of determination is viable and manages the application process.
Similar provisions apply under the Welsh pharmaceutical regulations, where local health boards make rurality determinations for their areas. The Welsh framework has similarities to the English controlled locality regime but differs in some procedural respects. TI Pharmacy Consultancy advises on rural pharmacy applications in Wales specifically for the Welsh regulatory environment.
Need professional advice?
The information above is for general awareness only. For advice specific to your situation, contact TI Pharmacy Consultancy for a free initial discussion.
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