Medis Pharma Ltd v NHS Resolution

DAVID PIEVSKY KC : Introduction

1. In this claim for judicial review the Claimant challenges a decision made by a committee of Primary Care Appeals (“PCA”), a service provided by the Defendant. On 25 November 2024 the PCA committee refused the Claimant’s application for inclusion in the pharmaceutical list for distance selling premises under Regulation 25 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the 2013 Regulations”). The consequence is that the Claimant is not permitted to operate the distance selling of medicines for the NHS.

2. As will be apparent from the factual summary set out below, the PCA committee’s main reason for refusing the application was that it was not satisfied that the Claimant would be delivering medicines safely and effectively, particularly by reference to the need to keep them at the correct temperatures throughout the delivery process. Factual background

3. On 4 December 2023, the Claimant applied to Kent and Medway Integrated Care Board for inclusion in the pharmaceutical list under Regulation 25 of the 2013 Regulations.

4. The application form dealt with various matters. One of the questions which had to be answered was as follows: “ Please explain how the pharmacy procedures used within the premises will secure (a) the uninterrupted provision of essential services during the opening hours of the premises to persons anywhere in England who request those services, and (b) the safe and effective provision of essential services without face-to-face contact between any person receiving the services, whether on their own or someone else’s behalf, and the applicant or the applicant’s staff… You must ensure that you provide sufficient information within this application form to satisfy NHS England or the relevant delegated integrated care board on the above points. ”

5. In response to that question, the Claimant provided information which related to a number of matters, under different headings. Under the heading “ Delivering Medicines ”, the Claimant said this: “Medicines will be placed in a pharmacy bag and then packaged in a heavy-duty (re-enforced) cardboard box or padded envelopes of suitable size, including bubble wrap and/or polystyrene filling if needed. For deliveries using our delivery driver, medicines can be delivered using standard pharmacy bags unless fragile items are included. The storage requirements will be included in the delivery bag or box, for example “Store under 25 degrees C” or “CD – safe custody required”. All bags will have a printed address label attached and will include the number of bags to be delivered. A note will be added to the bags to advise patients to return unwanted or expired medicines to a pharmacy and not to dispose of medicines in household waste, with a reference to our website for more information. The Pharmacy will enter into a technical agreement with City Sprint for delivery of items with special storage instructions and for those patients that fall outside the catchment area for local deliveries (as an alternative to Royal Mail for those patients). City Sprint drivers are DBS checked and trained in the secure transportation of medicines, complying with GDP regulations with regards to transportation. The company provides live updates and electronic proof of delivery. When booking a delivery, we will indicate the nature and storage requirements of the medicines to be delivered. The patient will be provided with a tracking number to track the status of the delivery online, if using Royal Mail or City Sprint. Controlled drugs and fridge lines will be kept in the CD cabinet and fridge respectively until the delivery driver is collecting. The deliver sheet will include information on the medicines to be delivered, such as “CD”, or “FRIDGE”. CDs and fridge items will be packaged in separate bags and the bags will have the appropriate sticker affixed to it. The delivery driver will verify the delivery sheet matches the delivery bags, including patient’s name, address, number of bags, and sign the delivery sheet. Once the delivery driver collects the medicines, he must ensure fridge lines are stored according to the storage instructions, and that CDs are placed in the dedicated section of the van. The delivery van must be locked at all times when the delivery driver is not in the vehicle, and medicines must be kept out of sight. For fridge lines, if there is a temperature excursion outside of the 2-8 degree 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. The pharmacy staff will arrange a second delivery for the patient with another supply. The technical agreement in place with our courier will ensure that they can provide us with temperature monitoring data on demand and within a reasonable timeframe. For CD deliveries, the delivery driver will sign the back of the prescription as the patient’s representative. CDs will be entered in the CD register at the point of collection by the delivery driver. The CD delivery sheet must be completed by the patient / representative. The delivery driver must check the identity of the patient / representative, unless already known. Medicines can only be delivered at the agreed address and only left with the patient or agreed representative. Medicines must not be left with neighbours or someone else residing at the address (unless agreed with patient), outside the house, in front porch or delivered through mailbox. Any medicines not delivered will be returned to the pharmacy on the same day and a “Missed you” card left for the patient. No medicines must be left in the van overnight. Undelivered CDs must be re-entered in the CD register, with a note explaining that it was a missed delivery. The patient must be contacted the following working day to rearrange delivery. On delivering medicines, the patient or authorised patient representative must sign the delivery sheet to accept the delivery of the medication.”

6. On 1 March 2024, the Interested Party sent a letter to Primary Care Support England, Pharmacy Administration Services, objecting to the application. The Claimant responded on 15 March 2024.

7. On 1 August 2024, the ICB granted the Claimant’s application. On 29 August 2024 the Interested Party appealed to the Defendant against the ICB’s 1 August 2024 decision.

8. The Claimant was invited to make representations and did so on 17 September 2024.

9. On 25 November 2024, as I have said, the Committee made the decision which is the target of this challenge. The overall conclusion, set out at paragraph 7.48, was that the Claimant’s application would be refused because the panel “ could not be satisfied that there are procedures that are likely to secure safe and effective provision of essential services as required by Regulation 25(2)(b) ”.

10. The committee was satisfied of all other relevant matters. It is important, in light of the issues raised by the Claimant, that I should set out the section of the decision in which the committee explained why it considered the Claimant’s application to have fallen short of what was required.

11. Paragraphs 7.36-7.42 of the decision stated: “7.36 The Committee was of the opinion that the procedures adopted by the pharmacy were not likely to secure the safe and effective provision by the Applicant of the following essential services: Providing ordered drugs or appliances 7.37 The Committee considered whether the Applicant had explained how drugs / appliances will be provided to the patient (including to ensure that (i) that cold ‘chain’ is maintained, where relevant, and (ii) that the requirements of the Misuse of Drugs Regulations 2011 and, in particular, Regulations 14 and 16, are met). 7.38 The Committee noted the information in the application form. [The Committee then quoted - in full - the extract set out at paragraph 5 above, from the Claimant’s application form] 7.39 Whilst the Committee noted the references to the cold chain being maintained, it was not clear from the information before it if this related to the pharmacy’s own delivery driver delivering fridge items. However, the Committee considered that if there was a deviation in temperature outside of the recommended limits, there was nothing provided as to how the driver would know that this had occurred and ensure that compromised medicines were not delivered. 7.40 The Committee went on to note that for those items that were delivered by courier, the Applicant stated “ The technical agreement in place with our courier will ensure that they can provide us with temperature monitor data on demand and within a reasonable time frame ”. The Committee was of the view that this appeared to be retrospective upon a request from the Applicant to the courier and that there was nothing provided to show how the courier would know in the first instance that there had been a deviation in temperature or what would happen if the temperature was not maintained. The Committee was of the view that a retrospective check presents the risk that a patient could technically have used medicines that had not been stored at the correct temperatures thus being compromised and any usage could have associated adverse consequences. 7.41 The Committee noted that whilst the Applicant had confirmed that controlled drugs would be delivered using a variety of methods including their own delivery driver, courier and Royal Mail, the information provided only appeared to relate to what would happen for a “ missed delivery ” if it was delivered by their own driver. The Committee was of the view that it had not been provided with any information as to what would happen in the event of a failed delivery of controlled drugs by either the courier or Royal Mail. 7.42 Taking all of the information before it into account the Committee was not satisfied that the Applicant had provided information sufficient to show that there would be compliance with paragraph 8(1) of Schedule 4.”

12. The Committee then reversed the decision of the IC, and refused the Claimant’s application. The proceedings

13. On 17 December 2024 the Claimant sent a letter before action. On 21 January 2025 the Defendant’s solicitors responded, indicating that the Defendant would not be taking an active stance in the proceedings, if brought, as it regarded itself as having a “ neutral ” role, analogous to that of a court or tribunal.

14. Judicial review proceedings were commenced on 4 February 2025. The Claimant sought a quashing order and a declaration that the Decision was made unlawfully. Three JR Grounds were pleaded. i) “ failure to consider the evidence (irrationality / Wednesbury unreasonableness) ” (Ground 1); ii) “ legality / failure to properly apply the relevant regulations ” (Ground 2); and iii) “ failure to give reasons ” (Ground 3).

15. The Defendant filed an Acknowledgment of Service, incorporating the standard document used to resist permission (“ Summary Grounds for Contesting the Claim ”). The Defendant stated that it intended only to make neutral submissions about the facts and the law, e.g. to assist the Court to understand why the Decision was made, and to take no further active part in the proceedings. The Defendant also asked the Court to rule that no order for costs should be made either in favour of or against it, relying on the case of R (Davies (No 2) v HM Deputy Coroner for Birmingham [2004] EWCA Civ 207 .

16. Permission was initially refused, on 10 April 2025, by David Pittaway KC sitting as a Deputy High Court Judge. Relevantly, Mr Pittaway KC made “ no order as to costs ”. The Claimant renewed the application for permission, and after an oral hearing on 17 June 2025 permission was granted - in respect of Grounds 1 and 3 only - by Mr Alan Bates sitting as a Deputy High Court Judge.

17. The Deputy Judge made directions, and these were recorded in his Order, which was processed and sent out on 25 June 2025. These included (at paragraph 5) a requirement for the Claimant to file and serve a hearing bundle by no later than 21 days before the substantive hearing, and (at paragraph 6) a requirement for the Claimant to file and serve a skeleton argument no later than 14 days before the substantive hearing.

18. The Deputy Judge also made the following costs order: “ costs in the case ”. The Defendant has subsequently applied to vary this aspect of the Deputy Judge’s order. The Defendant contends that the Deputy Judge made an error when saying “ costs in the case ”, and seeks variation of the order so that it provides for “ no order for costs against the Defendant irrespective of the outcome of the proceedings ”. Procedural matters

19. In due course the matter was listed for a one day substantive judicial review hearing to take place on 1 October 2025. The parties were informed of this on 4 July 2025.

20. When I started preparing for the hearing, I noted that the Court had not received any hearing bundles or skeleton arguments. I asked the Court lawyers to make enquiries. The Claimant’s solicitors then filed a hearing bundle on Friday 26 September 2025, and in due course a skeleton argument on Tuesday 30 September 2025 (i.e. the day before the hearing).

21. Before turning to the substantive questions that arise in this claim, I need to deal with the two procedural questions that have arisen. (1) What are the consequences of the Claimant’s failure to file a hearing bundle and a skeleton argument in accordance with the Court’s directions? (2) Should the Defendant’s application to vary the Deputy Judge’s 25 June 2025 costs order be granted? The Claimant’s failure to comply with the Court’s 17 June 2025 Order

22. In R (Liberty) v SSHD and SSFCO (Procedural Matters) [2018] EWHC 976 (Admin) , the Divisional Court (Singh LJ and Holgate J) considered a failure of the Defendants in that case to have filed a skeleton argument on time. As Singh LJ explained (at paragraph 3): “ It is common ground that an extension of time in such circumstances is akin to an application for relief from sanctions: see the decision of the Court of Appeal in R (Hysaj) v Secretary of State for the Home Department [2014] EWCA Civ 1633 [2015] 1 WLR 2472 , applying the well-known principles in Denton and others v T H White Ltd (Practice Note) ”. [2014] EWCA Civ 906 [2014] 1 WLR 3926 . That exercise involves three stages: (1) to identify and assess the seriousness of the breach; (2) to consider why the breach occurred; (3) to consider all the circumstances of the case, so as to enable the Court to deal justly with the application

23. The Divisional Court went on, applying Denton , to allow the Defendants to rely on their late skeleton argument, noting that the claim had raised “ matters of great importance ”. However, the Court also stated (paragraph 16): “ we do not take the view that breaches of deadlines of this sort, even of a day or two, should be regarded with equanimity ”. The Court ordered the Defendants to pay the Claimant’s costs of that application, on an indemnity basis. It noted, among other things, the lateness of the Defendants’ application to extend time, their apparent assumption that an extension would be granted (“ in effect presenting this as a fait accompli not only to the Claimant but also to this Court ”), and the impact on the “ timetable which the members of the Court had otherwise available to them for proper presentation for the substantive hearing ”.

24. In this case, the Claimant made no application to extend time before the substantive hearing commenced. It simply filed the late skeleton argument.

25. Applying the guidance I have set out above from the Liberty case, the relevant considerations appear to me to be as follows.

26. First, the breach in this case cannot be described as anything other than significant. The Claimant was required to file a skeleton argument by 17 September 2025. It failed to do so until 30 September 2025, the day before the substantive hearing. The hearing bundle ought to have been filed 21 days before the hearing. It was not filed until 5 days before the hearing. It was also incomplete, omitting highly relevant documents like the Defendant’s Acknowledgment of Service and Summary Grounds; and the pagination used for the Court’s bundle was inconsistent with the pagination in the bundle which Counsel had with him at the substantive hearing. In all the circumstances, the delays and other failures to comply with the directions in this case are significantly more serious than those which troubled the Divisional Court in the Liberty case.

27. Secondly, there was no good reason for these failures. On instructions, Mr Fazli told me that the Claimant’s solicitors had assumed that, once counsel who had attended the oral permission hearing was sent the directions and the notice of the substantive hearing which followed, he would proactively deal with drafting and filing a skeleton argument at the appropriate time. They did not, however, formally instruct him to do this. Nor did they check whether all was in hand, or react at all to the passing of the relevant deadlines, both of which they missed. Beyond the information I have recorded, the precise sequence of events remains somewhat unclear, but even on the basis of what I was told, it cannot realistically be suggested that there was any good reason for the breach of the Court’s Order that occurred in this case.

28. Third, the additional circumstances of the case seem to me to include the following. The Claimant did not, once aware of the breach of the Court’s order, file any application notice seeking relief from sanctions or an extension of time for filing a skeleton argument. Instead, it merely filed the skeleton argument the day before the hearing, seeking to rely on it as though no breach had occurred. As it was said to be in the Liberty case, this conduct is inappropriate: the litigant is failing to face up to the fact that they are in breach of a Court order, and is presenting a skeleton argument to the Court as, in effect, a fait accompli . But – unlike in the Liberty case – a costs sanction (e.g. “ Defendant to have its costs of the application to extend time in any event, on the indemnity basis ”) is not obviously workable in a case like this one, because the other parties have incurred no costs in relation to the application. And – while the claim is no doubt of great importance to the Claimant – it cannot I think be said to have raised matters of wider public importance, such as were said to be engaged in the Liberty case.

29. In light of the above factors, I concluded that I was minded to allow the Claimant to rely on and to refer to the hearing bundle which it filed on 26 September 2025, but that I was minded to refuse any application for an extension of time for the skeleton argument which it filed on 30 September 2025. In fairness to Mr Fazli, once I asked him to address me on the reasons for the breach, and whether the Claimant was or was not making an extension of time to file a skeleton argument, he conceded that no such application could realistically succeed. I agree. I explained to Mr Fazli that the consequence of this was not that he could not put a case at all, rather that he would need to rely very closely on the way the claim had originally been put in the Claimant’s Statement of Facts and Grounds (in effect treating that document as his skeleton argument), along with relevant passages from the bundle in support. He agreed that this was the appropriate course in the circumstances. That is the approach I have taken. (2) Should the Deputy Judge’s “costs in the case” ruling be replaced with “no order as to costs, irrespective of the outcome of the proceedings”?

30. Having considered the Defendant’s application to vary the Deputy Judge’s costs order, and Mr Fazli’s response to it, I declined to grant it. I was not content to proceed on an assumption that the Deputy Judge was unaware of (or had “ overlooked ”, as the Defendant put it) the Defendant’s written request for “ no order as to costs ”. It is equally if not more likely that he was well aware of the costs order sought, but did not find that proposal satisfactory. Relatedly, I am not persuaded that it would have been right to characterise the Defendant’s stance in these proceedings as having been entirely “ neutral ”. Its participation was limited, and its brief written submissions were moderate and careful. They assisted the Court. But at several points in the Summary Grounds of Resistance the Defendant sought to ‘push back’ on points made by the Claimant, both in relation to issues of fact and alleged errors said to have been made by the committee. It would not be right, I think, to treat the Defendant as having attained quite the same neutral status as a party who had taken no part in the proceedings at all, or who had merely responded saying that it was neutral as to the outcome. In any event, and in particular given the Claimant’s subsequent breach of a court order, I considered that the right course would be to leave any disputes about who should bear the costs of these proceedings until the conclusion of the case. The substantive issues Ground 1

31. 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 ”.

32. 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) First, NHS England was entitled, indeed bound, to reject the Claimant’s application, if not satisfied that the Claimant’s procedures were “ likely ” to secure the “ safe and effective provision ” of medicines by its staff to the intended recipient (see Regulation 25(2)(b) of the 2013 Regulations); ii) Secondly, the panel was entitled, indeed bound, to overturn the ICB’s decision (which had granted the Claimant’s application) if it considered that the Claimant’s procedures were not likely to secure the safe and effective provision of medicines to recipients; and iii) Thirdly, that the case falls into classic Wednesbury review territory, not (for example) engaging the concepts of proportionality or anxious scrutiny.

33. 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.

34. 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).

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

41. 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 ”.

42. Although the SFGs do not make these additional points, I have also noted, in this context, that i) there is no evidence of any specific expectation set out in the NHS material that applicants need to explain clearly how temperatures are going to be monitored, in real-time; and ii) this matter was not specifically raised by the Interested Party when objecting to the application either at the first stage or the appeal stage.

43. 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.

44. 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. i) It is well established that a Tameside complaint (see Secretary of State for Education and Science v Tameside MBC [1977] AC 1014 ) will only succeed if it can be shown to have been irrational for the public authority to proceed on the basis that it possessed the information necessary for its decision. See e.g. R (Balajigari) v Secretary of State for the Home Department [2019] 1 WLR 4647 , per Underhill LJ at paragraph 70. ii) Here, the Claimant was asked upfront to provide information in order to satisfy the committee that it could provide the relevant medicines “ safely and effectively ”. It was a matter for the Claimant how to present that material. Any reasonable Claimant applying to the NHS for permission to deliver medicines which need to be kept at particular temperatures if they are to be safe and effective would have appreciated that they had to provide the NHS with adequate information about how that requirement was going to be achieved. iii) The committee, applying its expertise and judgment, was evidently not expecting an iterative process in which the information could be drip-fed to it, following interviews, investigations, or a question-and-answer process. iv) I cannot conclude that it was unfair or irrational for the panel to proceed in that way, and to expect applicants to provide whatever information was relevant and necessary in writing, and upfront, in the application itself. Nor was the committee, in my Judgment, acting unreasonably or irrationally when it determined the application for itself on the information it had without making further enquiries.

45. There is also this problem, which (having raised it with counsel) I consider to be insurmountable. i) There is – as I have already mentioned - no witness statement from the Claimant before the Court. There are assertions in paragraph 20 of the SFGs (backed up by a statement of truth) that “ delivery vehicles ” have “ calibrated data loggers providing real time temperature monitoring to the drivers ”, and that it is “ industry knowledge ” that they send a notification to the driver if there is any deviation. But there is no supporting evidence of these matters, and there is no explanation about whether this arrangement applies to all the delivery drivers delivering the Claimant’s medicines, or only to the Claimant’s own drivers. That lack of clarity is striking because a very similar problem was picked up by the panel in its decision. ii) I would also have expected to see at least some evidence, e.g. in a witness statement or in supporting documentation, explaining what the “ industry knowledge ” about temperature monitoring in the medical delivery sector was, if the Claimant wished to rely on such alleged knowledge. iii) It follows, I think, that there is a significant evidential gap in the Claimant’s case, relating to what would have occurred had the panel done what the Claimant now says was legally required of it, i.e. ask the Claimant for more information about whether all relevant drivers would have real-time temperature monitoring, and if not how they would otherwise be able to detect temperature deviation. iv) Whether that evidential gap is analysed as demonstrating that the panel’s decision not to make further enquiries could not have been irrational in the required sense, or as demonstrating that its decision not to do was not material to the outcome, does not seem to me to matter.

46. Ground 1 does not succeed. Ground 3

47. Ground 3, as pleaded, is as follows: “ the PCA decision was unlawful because no, or no proper reasons, were given for it ”.

48. Mr Fazli did not press this point at the substantive hearing, and in my Judgment he was right not to do so. The PCA committee’s decision was set out in a 53-page document. There was extensive and close reasoning, including in relation to the critical issue of temperature control. The relevant public law requirement is, in essence, for the reasons provided to be intelligible and adequate. The reader must be able to understand why the decision was made, and how any principal controversial issues were resolved: see e.g. South Bucks DC v Porter [2004] 1 WLR 1953 per Lord Brown at paragraph 36. As Fordham J noted more recently in R (Alnoor) v Secretary of State for the Home Department [2025] EWHC 922 (Admin) at paragraph 28(ii), adequate reasons can require “ clarity which eliminates genuine doubts as to what was decided and why ”, and “ grappling with the principal controversial issues ”. In my Judgment, the committee’s reasons in this case did all of those things, both generally and in relation to the particular concerns which led to the outcome. The reasoning in the decision, as already set out, conveyed an unanswered concern about how the drivers would know whether relevant medicines had been exposed to temperatures outside the recommended limits; the unacceptable risk of patients receiving medicines that had not been kept at the correct temperatures during the delivery process; and the lack of adequate information about how couriers or post office drivers might deal with the problem of missed deliveries. I find it impossible to accept the contention that this reasoning (which is also, in my Judgment rational – see above) is legally inadequate.

49. Ground 3 does not succeed. Conclusion

50. The claim is dismissed.

51. The parties agreed, following circulation of this judgment in draft, that the order should state that the claim for judicial review is dismissed, and that there is no order as to costs of these proceedings. That is the order I will make.