With almost 90% of Scots visiting a pharmacy each year, many owners are looking to grow their high street presence. But expansion in Scotland is tightly regulated. To guard against abuse and oversupply, every NHS board keeps a pharmacy list and only those on it can provide pharmaceutical services in a given area (other than doctors or dentists). Entry is controlled by prescriptive rules under the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 which are interpreted strictly by the courts.
Whether you are opening a new branch or relocating an existing one, understanding the process and getting the right legal support is essential. This guide outlines the application process.
Building a Strong Application
Before applying to join the pharmacy list, you must work with the local NHS board to assess the need for a new pharmacy in the area. This includes:
- Completing a pre-application process to examine the board’s health plan and establish the scope of your proposal;
- Conducting a joint community consultation to collect community opinion; and
- Preparing a consultation analysis report (CAR) that shows how you gathered feedback and what the community needs.
Applications are decided by the board's Pharmacy Practices Committee (PPC). The regulations state that to succeed, you must show your new pharmacy is necessary or desirable to ensure adequate provision of pharmaceutical services in the area. Strong evidence is key, such as considerations relating to current provision (ie stock levels, waiting times, error rates etc), neighbourhood boundaries, and current and future demographics.
The PPC only considers submitted evidence, so your supporting documents must be complete and persuasive. Whilst the CAR usually carries weight, recent judicial decisions have shown that low response rates can weaken its persuasiveness. PPC site visits also play a significant part in decisions.
Submitting Your Application
Applications are made on a Form A which is submitted along with all supporting evidence to the PPC. The regulations outline what information must be included such as:
- The services you will offer;
- Your intended start date;
- Proposed opening hours;
- The neighbourhood you will serve; and
- Evidence explaining where current provision falls short.
Once submitted, the PPC will notify interested parties of the application and they have 30 days to make representations. Their views will be considered alongside your evidence in the PPC's decision-making.
Could Your Move Be a Minor Relocation?
Even those currently on the list may have to submit an application if there is a change in circumstance. However, if you are relocating your premises within the same neighbourhood and the move will not significantly affect other pharmacies, your application may qualify as a minor relocation. This is advantageous because the PPC can approve it without applying the full adequacy test.
However, these applications are scrutinised closely by the PPC to ensure that they fit the statutory definition of minor relocation. The PPC will evaluate the extent of the impact by considering any competitive shifts, including whether the new premises is closer to a health centre or transport hub than existing providers.
Hearings and Decisions
If there is opposition, the PPC is likely to hold a hearing. Its decision-making process in establishing whether a pharmacy should be added to the list is underpinned by market forces and has two stages:
- Assess whether current provision is inadequate; and
- If so, decide whether your proposal is necessary or desirable to secure adequate provision in future
Recent case law has emphasised that whilst necessary means no more than make up current deficiencies, some over-provision is permitted if an application would be desirable to secure long-term service levels. Importantly, this is not an assessment of the desirability of the premises itself but instead is scrutinising its potential role in improving the local pharmacy market overall.
But remember: what matters is your pharmacy’s potential contribution to the local market, not the desirability of the premises itself. Clear, accurate oral evidence is essential at hearings as misinterpreted submissions have caused appeals to fail.
Appeal
Once a decision has been made by the PPC, applicants and interested parties can appeal to the National Appeal Panel (NAP), but only on limited grounds:
- A procedural error;
- Failure to properly outline the facts or reasons; and
- Misapplication of the regulations
Recent court judgments have clarified the relationship between the PPC and NAP. The PPC is treated as the expert body which assesses applications by hearing and weighing evidence against the statutory tests, so the NAP shows deference and will only step in if the PPC was plainly wrong. If an appeal succeeds, the case goes back to the PPC for a limited reconsideration as directed by the NAP, not a full rehearing.
Successful grounds of challenge that have been successful at the NAP have focused on the PPC failing to apply the correct legal test, making a decision whilst not quorate, or failing to properly explain the facts upon which its decision was based.
Judicial Review
If you have exhausted all other routes, you may be able to challenge the NAP’s decision through judicial review in the Court of Session. This is a remedy of last resort and is not an appeal on the merits. The court will only consider whether the NAP acted lawfully when dealing with an appeal against the PPC's decision. Judicial review is also the only way to challenge a PPC decision on a minor relocation.
A review must be brought within three months of the NAP making the decision and you must have sufficient interest to petition, which an applicant or other listed pharmacy owner will usually meet.
How MFMac Supports Pharmacy Owners
Growing your high street presence can bring significant commercial benefits, but navigating the regulatory framework is demanding. MFMac’s specialist healthcare and pharmacy team advises owners across Scotland across all aspects of this complex process. Whether you are expanding, relocating or defending your position, we help you move confidently through every stage of the process.
This article has been co‑authored by Josh Chambers, trainee at MFMac.
