Assura Pharmacy Ltd, R (on the application of) v National Health Services Litigation Authority (Family Health Services Appeal Unit)

The statutory control-of-entry test for NHS pharmaceutical lists requires a structured assessment. The decision-maker must identify the relevant neighbourhood, decide whether existing pharmaceutical provision is adequate, and, only if it is inadequate, decide whether the proposed provision is necessary or desirable to secure adequacy.

“Adequacy” is an absolute standard, assessed with a wide margin of judgment. The listed factors in the regulations, including access, availability and reasonable choice, must be considered but are not determinative and need not receive particular weight. Choice requires an alternative service; a single provider may therefore mean no choice, although that fact does not itself determine the application.

Assura applied for admission to the NHS pharmaceutical list in three neighbourhoods. The relevant Primary Care Trusts refused the applications, and the Pharmacy Appeals Committee dismissed Assura’s appeals. Assura sought judicial review in three claims.

The Freckleton claim concerned whether the decision-maker had properly considered the choice factor where only one pharmacy served the neighbourhood. The Todmorden claim concerned two pharmacies operated by the same company and alleged failures concerning choice, demand and reasons. The Tunbridge Wells claim concerned competing applications to remedy an admitted deficiency and whether a material mistake of fact about Saturday opening hours justified judicial review.

1. Freckleton. The claim was allowed. Regulation 12 required the decision-maker to consider reasonable choice as a factor distinct from access and availability. The absence of any alternative pharmacy meant that there was no choice of service, although the absence of choice was not determinative. The PAC and its panel were impressed by the existing service but failed substantively to consider the effect of the absence of choice when assessing adequacy. The decision was therefore unlawful, quashed and remitted.

2. General test. The proper approach was three-stage: identify the neighbourhood; determine whether existing provision was adequate, having regard to all relevant factors; and, if provision was inadequate, determine whether the proposed provision was necessary or desirable to secure adequacy. “Adequate” was an absolute concept. The decision-maker could consider probable, but not speculative, future developments. The assessment involved a wide qualitative judgment, challengeable only on ordinary judicial-review grounds. The reasoning in Lloyds Pharmacy Limited v The National Appeal Panel and E A Bairds (N’Ards) Limited was preferred, although the practical consequences of that analysis and R (Lowe) v The Family Health Services Appeal Authority were regarded as substantially similar.

3. Choice. Regulation 12(2)(b) was a unitary factor concerning reasonable choice of pharmaceutical services, taking account of the services available and the persons providing them. It did not give choice pre-eminent weight or create an in-built preference for competition. A decision-maker could find provision adequate despite limited or absent choice, provided the factor had genuinely been considered.

4. Todmorden. The claim was dismissed. The PAC had lawfully considered demand, choice, the common ownership of the pharmacies and the absence of choice for some directed services. Its conclusion that provision remained adequate was open to it, and its reasons were sufficient.

5. Tunbridge Wells. The principles in E v Secretary of State for the Home Department applied to PAC decisions. A mistake of fact may amount to an error of law where an existing fact or evidence was mistaken, objectively verifiable, not attributable to the claimant, and materially influenced the decision. Although the PCT and PAC had materially misunderstood the Pharmaceutical Needs Assessment, Assura had received the document and failed to raise the error promptly. The mistake was therefore materially contributed to by Assura and did not produce the necessary unfairness. The claim was dismissed.

These were first-instance judicial review claims. The judgment quashed and remitted the Freckleton PAC decision, and dismissed the Todmorden and Tunbridge Wells claims.