Medis Pharma Ltd loses judicial review challenge over NHS distance selling pharmacy refusal

In a recent High Court judgement, David Pievsky KC sitting as a Deputy Judge dismissed Medis Pharma Ltd's judicial review challenge against NHS Resolution's decision to refuse its application for inclusion in the pharmaceutical list for distance selling premises.

The case centred on concerns about the safe delivery of temperature-sensitive medicines. Medis Pharma had applied to Kent and Medway Integrated Care Board in December 2023 under Regulation 25 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, seeking permission to operate distance selling of medicines for the NHS. Whilst the ICB initially granted the application in August 2024, this decision was overturned following an appeal by Optimal Wellness Services Ltd.

The Primary Care Appeals committee's November 2024 decision focused primarily on inadequate procedures for maintaining the cold chain during medicine delivery. The committee expressed particular concern about how delivery drivers would know if temperature deviations had occurred during transit. Despite Medis Pharma's assurances about using trained couriers complying with good distribution practice regulations and having technical agreements with City Sprint for specialised deliveries, the committee found the information insufficient.

The committee identified two critical gaps in the application. First, whilst the applicant mentioned temperature monitoring capabilities, there was no clear explanation of how drivers would receive real-time alerts about temperature excursions. The reference to obtaining temperature monitoring data "on demand and within a reasonable timeframe" suggested retrospective checking rather than contemporaneous monitoring, creating risks that patients might receive compromised medicines. Second, the procedures for handling failed deliveries of controlled drugs appeared to apply only to the pharmacy's own drivers, not to external couriers or Royal Mail.

Medis Pharma challenged the decision on grounds of irrationality and inadequate reasoning. They argued the committee had ignored evidence about temperature monitoring procedures and should have made further enquiries rather than refusing the application outright. The claimant suggested it was "industry knowledge" that delivery vehicles equipped with calibrated data loggers automatically notify drivers of temperature deviations.

The Deputy Judge rejected these arguments comprehensively. He found the committee was rationally entitled to expect applicants to provide complete information upfront rather than through an iterative process. The absence of witness evidence or documentation supporting claims about "industry knowledge" or specific temperature monitoring capabilities proved fatal to the challenge. The court emphasised that bare assurances about compliance with GDP regulations, without detailed explanation of actual procedures, were insufficient to satisfy safety requirements.

Procedural issues also arose when Medis Pharma filed its hearing bundle and skeleton argument significantly late, breaching court directions. Whilst the court permitted reliance on the hearing bundle, it refused to grant an extension for the late skeleton argument, requiring counsel to rely primarily on the original statement of facts and grounds.

The judgement underscores the stringent requirements for pharmaceutical distance selling applications, particularly regarding temperature-sensitive medicines. The committee's approach, demanding clear and comprehensive evidence of safety procedures rather than general assurances, was upheld as both rational and properly reasoned. The decision highlights the importance of providing detailed, specific information about operational procedures when seeking regulatory approval for medicine distribution, particularly where patient safety considerations are paramount.