AC-2025-LON-000553 - [2025] EWHC 2616 (Admin)

The Claimant contends that the decision was “irrational or Wednesbury unreasonable” because it “defied logic and was a decision that no sensible decision maker who had applied their mind to the subject matter would have arrived at”. In general terms, it contends that the committee “did not engage properly with the documentary evidence and submissions that the Claimant provided”.

There are in effect seven pleaded particulars of this general complaint. I address them in turn below. Before I do that, I should record that Mr Fazli accepted the following three propositions about the relevant legal framework:

I will say something briefly about why I consider the third of the above concessions is correct. There are considerations about institutional competence: this case involves a challenge to a panel charged with exercising a judgment over matters within their specific expertise and experience. The decision also touches on issues of patient safety. There are also considerations about impact: whilst the decision is naturally of great importance to the Claimant, that does not distinguish it from the many cases about licences or other regulatory decisions in which the Courts regularly accord appropriate respect to the expertise of the decision-maker. It is not comparable to the cases in which anxious scrutiny has been said to be required.

The recent case of R (KP) v Secretary of State for Foreign, Commonwealth and Development Affairs [2025] EWHC 370 (Admin) sets out at paragraphs 56-57 examples of the sorts of flaws which will amount to irrationality in the required sense: (i) a logical error or critical gap in the decision’s reasoning, (ii) a failure to have regard to a mandatory relevant consideration, or (iii) a decision whose outcome which is so unreasonable that no reasonable authority could ever have come to it (or one which is outside the range of reasonable decisions open to the decision-maker).

First, the Claimant contends (SFGs, paragraph 18) that the committee was irrational when concluding at paragraph 7.35 of its decision that “if the application was to be granted, the Applicant would not be able to provide any appliances” and that this was a “deficiency” in its application. Mr Fazli submitted that this was an illogical and irrational approach, because it ignored the fact that the Claimant was perfectly entitled to apply for inclusion on the basis of selling medicines and not appliances. In my Judgment this criticism involves a misreading of the Decision. The committee did not treat the Applicant’s inability to provide appliances as a “deficiency” of the application to provide medicines. Read fairly and in context, the comment at the end of paragraph 7.35 (quoted above) was simply recording the fact that the Claimant was not intending or seeking to provide appliances, and would not be able to do so whatever the fate of the application, and so the Committee did not need to address evidence or standards relating to that topic.

Secondly, it is said (SFGs, paragraph 19) that the committee’s statement at paragraph 7.39 of its Decision, that it had “no information” about how a driver would know that a temperature deviation had occurred so as to ensure that compromised medicines were not delivered, was one that “contradicts” the evidence quoted from the Claimant’s application which had stated that “for fridge lines, if there is a temperature excursion outside of the 2-8 [degrees] C temperature, the delivery driver must notify the pharmacist immediately and return any affected medicines to the pharmacy, where these will be quarantined pending investigation”. However, in my Judgment there is no contradiction between the two statements. The committee was saying that there was no information in the application explaining how a driver might discover that a relevant temperature deviation had occurred. The passage relied on by the Claimant is not about that issue. It cannot create a basis for condemning the committee’s concern as irrational. It is, properly construed, concerned with what the driver must do once he is already aware of such a deviation. I reject this aspect of the challenge.

Thirdly, it is said (SFGs, paragraph 20) that delivery loggers are equipped with calibrated data loggers providing real time temperature monitoring to the drivers, and that it is “industry knowledge” that these data loggers automatically and contemporaneously send a notice to the driver if there is a relevant temperature deviation. However, the problem with this contention is that there was (and is) no evidence to support it. There is, for example, no witness statement from the Claimant explaining what equipment its delivery drivers have, or how this can be used to monitor temperatures in real time. Nor is there any evidence before the Court describing or explaining any relevant “industry knowledge”. Nor is there any material before the Court showing that the committee was provided with any such evidence. The relevant question which arises, it seems to me, is whether it was irrational for the committee not to have concluded - on the material with which it had been provided - that drivers would be aware, during the delivery process itself, of relevant temperature deviations when they occurred. I am unable to say that it was. The effect of this aspect of the Claimant’s case, if accepted, would be that the committee ought to have assumed the adequacy of arrangements which had not in fact been explained to it.

Fourthly, it is said (SFGs, paragraph 21) that the committee “incorrectly” characterised temperature monitoring (at paragraph 7.40 of its decision) as “retrospective”, with “nothing provided to show how the courier would know in the first instance that there had been a deviation”. The Claimant points out that its application had specifically confirmed that City Sprint drivers (the couriers to be used by the Claimant for certain types of delivery) were “trained in the secure transportation of medicines, complying with GDP regulations with regards to transportation”, with what the Claimant described as “live updates and real-time monitoring”, and “temperature monitoring data on demand”. Leaving aside the problem that it is not for the Court to determine whether the committee’s conclusions were “correct”, only whether they were rational, these points do not in my Judgment undermine the cogency or rationality of the points made by the committee at paragraph 7.40 of its decision (quoted at paragraph 11 above). In particular, the committee was rationally entitled to consider that the Claimant’s application, by referring in particular to an ability to seek temperature monitoring data from its couriers “on demand” and “within a reasonable timeframe”, had given the impression that this data was not expected to be available automatically or in real time. In that sense, it was “retrospective” data, concerning something that had happened in the past and available on request rather than in any event. I am also unable to accept Mr Fazli’s submission that if the couriers were “trained in the secure transportation of medicines” it is “obvious” that they could and would ensure that the medicines are kept at the correct temperature. That submission reads too much into the word “secure”. There is no evidence before the Court about the training said to be provided, whether in relation to temperature monitoring or otherwise. The reality is that the committee evidently did not consider it to be at all “obvious” that the training said to be available to the couriers meant that they would be able to monitor relevant temperatures appropriately, and I cannot conclude that its approach was irrational. In my Judgment, the committee was rationally entitled to conclude, on the material before them, that if the application were to be granted, there would be a risk that patients would be receiving medicines that had not been stored at the correct temperatures, without the courier or driver being aware, and that this might lead to adverse consequences.

Fifthly, it is said (SFGs, paragraph 22) that the “GDP regulations” require active temperature monitoring during transit. Mr Fazli submitted that it was irrational of the panel not to treat the fact that the Claimant had said that it would comply with those “GDP regulations” as sufficient to allay any concerns. I reject that argument. It was not irrational for the committee to decline to treat a bare assurance of compliance with “GDP regulations” as sufficient. Indeed, there is nothing in the claim form (or any other evidence before the Court) explaining what the Claimant actually meant by its references to “GDP regulations” or precisely which provisions were being referred to or what is said in them. In oral submissions counsel clarified that the Claimant had been intending to refer to GDP [good distribution practice] standards, deriving from guidance issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”). None of those “standards” were before the Court either, and I received no assistance from counsel about which of them might be in play in this case. It seems to me that the same objections apply, whether the Claimant was intending to rely on regulations on the one hand, or MHRA guidance on the other.

Sixthly, it is said (SFGs, paragraph 23) that when the panel concluded that there was insufficient information about what would happen in the event of failed deliveries of controlled drugs by couriers / Royal Mail drivers (see paragraph 7.41 of its Decision), it ignored passages in the Claimant’s application which had stated that (1) “undelivered [controlled drugs] must be re-entered in the CD register with a note explaining it was a missed delivery. The patient must be contacted the following working day to rearrange delivery”; and that (2) drivers would have 24/7 access via fob and that pharmacists would remain on premises to receive any returns when required. I see no basis upon which I can properly conclude that the panel ignored this material. The point made by the panel, which cannot be said to be irrational, is that the arrangements for missed deliveries appeared to relate only to situations in which the Claimant was using its own delivery drivers. The committee was evidently concerned with what would happen in those cases where the Claimant was using other drivers, such as couriers or Royal Mail drivers, who would not have (and indeed, should not have) “24/7” access to a pharmacist’s premises, “via fob” or otherwise. I cannot conclude that the concerns expressed by the committee about this situation were irrational.

Finally, it is said (SFGs, paragraph 26) that the committee ought to have made further enquiries, or conducted further assessments, interviews, or site visits, before rejecting the application, and that its failure to do so led it to make assumptions or to reach incorrect conclusions on the facts. Mr Fazli, relying on what was said about the Tameside duty at paragraph 53 of R (Hartford Care Limited) v Secretary of State for the Home Department [2024] EWHC 3308 (Admin), said that the panel’s obligation was to have “due regard to the need to take steps to gather relevant information in order that it can properly take into account such information in the context of the particular decision it has to make”.

Although the SFGs do not make these additional points, I have also noted, in this context, that

I accept that the Claimant is bound to feel disappointed, having submitted an application which was for the most part thorough and careful, and which covered many different issues, only to be told that it had fallen short in relation to one particular issue (which had not squarely been raised by those objecting to the application). It certainly would not have been unreasonable for the committee to decide that it should simply ask the Claimant for further information about how the Claimant intended to ensure appropriate temperature monitoring during transit.

However, it does not follow, and it is not in my Judgment the case, that the process or approach taken by the committee was unlawful.

There is also this problem, which (having raised it with counsel) I consider to be insurmountable.

Ground 1 does not succeed.