Medis Pharma Ltd v NHS Resolution

In reviewing a specialist regulatory decision concerning patient safety, the court applies ordinary Wednesbury principles where the decision-maker is exercising expertise in licensing and pharmaceutical regulation. The court need not substitute its own assessment of the evidence or require an iterative inquiry where the applicant was asked to provide the necessary information upfront. A failure to make further enquiries is unlawful only where it was irrational to proceed on the information available, or where the omitted enquiry was material to the outcome. Bare assurances of compliance with unspecified standards do not necessarily answer a regulator’s concern. Reasons are adequate where they are intelligible, explain the outcome, and address the principal controversial issues.

Medis Pharma Ltd applied for inclusion in the pharmaceutical list for distance selling premises under Regulation 25 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. The application was initially granted by the relevant integrated care board, but an appeal committee of NHS Resolution refused it. The committee was not satisfied that the proposed procedures would secure the safe and effective delivery of medicines, particularly medicines requiring temperature control, and was also concerned about failed deliveries of controlled drugs by couriers or Royal Mail.

Medis sought judicial review on irrationality, legality and failure to give reasons. Permission was granted on the irrationality and reasons grounds. The central issues were whether the committee had irrationally misunderstood or ignored the application, whether it was required to make further enquiries, and whether its reasons were legally adequate.

1. Outcome. The claim for judicial review was dismissed. The committee’s decision was rational and adequately reasoned.
2. Applicable standard. The challenge fell within ordinary Wednesbury review. The decision concerned a specialist panel exercising judgment on pharmaceutical safety and licensing. Neither proportionality nor anxious scrutiny was required. Irrationality may arise from a logical error or critical gap, failure to consider a mandatory relevant consideration, or an outcome outside the range of reasonable decisions.
3. Temperature-control evidence. The committee was entitled to distinguish between instructions stating what a driver should do after discovering a temperature excursion and information explaining how the driver would discover the excursion. References to data being available from a courier “on demand” rationally suggested retrospective rather than automatic real-time monitoring. Training in secure transportation and a bare reference to unspecified GDP regulations did not require the committee to assume that effective temperature monitoring arrangements existed.
4. Further enquiries. Applying Tameside principles, a duty to make further enquiries arises only where it was irrational for the authority to proceed on the information available. The applicant had been asked to provide sufficient information upfront. The committee was entitled to determine the application on the material supplied rather than initiate an iterative question-and-answer process. The absence of evidence showing what further enquiries would have established also meant that any failure to enquire was not shown to be material.
5. Controlled drugs. The committee rationally distinguished arrangements for missed deliveries by the applicant’s own drivers from arrangements involving couriers or Royal Mail, for which the application provided insufficient information.
6. Reasons. The committee’s extensive reasons identified the unresolved temperature-monitoring concern, the risk of compromised medicines reaching patients, and the lack of adequate arrangements for failed controlled-drug deliveries. They enabled the reader to understand why the application was refused and how the principal controversial issues were resolved.
7. The final order was that the claim was dismissed, with no order as to costs.

This was a first-instance judicial review in the Administrative Court. The claim challenged the decision of a Primary Care Appeals committee, which had reversed the integrated care board’s grant of the application.