Mak Systems Group Limited v Velindre University NHS Trust

This application arises out of the procurement by the Welsh Blood Service (“WBS”) of a new blood establishment computer system (“BECS”). The WBS is an operating division of the defendant Trust.

WBS is the body responsible for the supply of blood and blood components to NHS Wales. It has a statutory responsibility to collect and maintain detailed records relating to individual blood donors; the blood testing process; processing of donated blood; and storage and supply of all donated blood components. Since the 1980s, these records have been held in a digital system, a BECS, which manages the process and infrastructure.

The claimant (“MAK”) has been the incumbent supplier since 2015 deploying its eProgesa software.

The procurement began on 11 October 2024 by advertisement on the Find a Tender website with an invitation to tender (“ITT”). Annex A to the ITT contained the Specification with nearly 300 individual requirements. Bids were submitted by 11 November 2024. Bidders were notified on 9 May 2025 that the successful bidder was GPI SpA (“GPI”), the Interested Party. GPI’s total score was 81.50% and MAK’s was [REDACTED] and MAK placed third amongst the bidders. Following correspondence from MAK alleging breaches of the Public Contracts Regulations 2015 (“PCR”) a revised award notification was issued on 23 May 2025.

MAK made further allegations of breach of the PCR and, following correspondence and some early disclosure, MAK commenced proceedings on 19 June 2025. On 26 June 2025, MAK served Particulars of Claim running to 94 pages. The Particulars of Claim make extensive allegations of different types of breaches including the contention discussed below that the defendant ought to have excluded GPI from the tender, lack of transparency, failure to investigate abnormally low tenders and scoring challenges. The Particulars of Claim include challenges to over 100 scores and MAK alleges that the reasons provided for over 350 scores awarded were inadequate. The allegations are comprehensively denied by the defendant.

The commencement of the proceedings brought into effect an automatic suspension under Regulation 95(1) preventing the defendant from entering into a contract. On 9 September 2025, the defendant issued this application to lift the suspension (the “AtL”). On 17 October 2025, MAK issued an application for an expedited hearing.

MAK’s evidence on these applications was given in:

The defendant’s evidence was given by:

GPI gave evidence by the statement of Paolo Stofella, International Products Director of the GPI Group.

On 10 November 2025, Constable J gave permission to MAK to serve evidence in reply limited to the expedition application. MAK served three statements from Mr McCarthy, Mr Sajot and Mr Rudd-Clarke purportedly in accordance with that Order. The defendant objected to the admission of this evidence on the grounds that it was not limited to or indeed relevant to the expedition application and was in reality further evidence on the AtL, principally as to patient safety and public benefit. There was a belated application to serve evidence in response to the statement of Mr Stofella but that application was made only after it was apparent that there was an objection to the evidence that had been served under the guise of responsive evidence on the application for expedition. For the reasons I gave at the time, I refused permission to admit this further evidence and it followed that I also refused permission to rely on a second statement of Mr Stofella which had been served in response.

It is well established that an application to lift is to be considered on American Cyanamid principles.

The questions for the court were neatly set out by O’Farrell J in Camelot Lotteries Ltd v Gambling Commission [2022] EWHC 1664 (TCC) at [48] as follows:

“(i)

Is there a serious issued to be tried?

(ii)

If so, would damages be an adequate remedy for the claimant(s) if the suspension were lifted and they succeeded at trial; is it just in all the circumstances that the claimant(s) should be confined to a remedy in damages?

(iii)

If not, would damages be an adequate remedy for the defendant if the suspension remained in place and it succeeded at trial?

(iv)

Where there is doubt as to the adequacy of damages for either of the parties, which course of action is likely to carry the least risk of injustice if it transpires that it was wrong; that is, where does he balance of convenience lie?”

Between them the skeleton arguments of MAK and the WBS cite virtually every case decided on the application of the principles applicable to an AtL. It is unfortunate that this extensive citation of authority, much of which is case and fact specific, is a characteristic of these applications. Only a few of these authorities will be referred to in this judgment. That is not to be taken as any indication that this body of authority is unfamiliar to the court or not considered but rather as an indication that the court does not regard the decisions as material to the facts of this case.

Perhaps unsurprisingly, the defendant concedes, albeit solely for the purpose of this application, that there is, in this case, a serious issue to be tried.

For the claimant, Mr West KC submitted that the next question the court should then ask itself is whether there could and should be an expedited trial. Mr West relied on the observations of the Court of Appeal in DWF LLP v Secretary of State for Business Innovation and Skills [2014] EWCA Civ 900 at [50]. Having found that the first hurdle, that of whether there was a serious issue to be tried, had been overcome, Sir Robin Jacob said:

“… the next question is to ask how long a period the suspension might be and to what extent it should be in force. You cannot assess the later Cyanamid questions without this essential background. ….”

I note that in this case the hearing was in June, the judgment was handed down in July and the court was told that there could be a trial in August or September and that the parties could be ready for such a trial. The court declined to lift the suspension.

In Lancashire Care NHS Foundation Trust v Lancashire County Council [2018] EWHC 200 (TCC), Fraser J refused to lift the suspension for reasons that were unrelated to availability of an expedited trial. However, at [44], and after having reached his conclusions on the American Cyanamid principles, he observed that there was another factor in favour of not lifting the suspension which was that the court could offer an expedited trial in only a few months.

I do not regard the DWF case as binding authority as to the order in which the issues ought to be addressed but the logic of the argument is that, for the purpose of the AtL, once it is conceded that there is a serious issue to be tried, if that issue can be determined on an expedited basis, there is, or at least may be, a strong argument for leaving the suspension in place pending the outcome of the trial. The availability of an expedited trial might, therefore, be an answer to the issues as to adequacy of damages to either party and the balance of convenience.

Having said that, the treatment of the issue of expedition as some kind of overarching consideration, does not sit easily with established principles as to the factors the court will consider on an application for expedition. It is common ground that those factors are set out in W L Gore & Associates GmbH v Geox SpA [2008] Civ 622 at [26] as follows:

In Inhealth Intelligence Ltd v NHS England [2022] EWHC 2471 (TCC), Fraser J noted the potential desire in every procurement case to expedite the hearing. He emphasised that there must be good and cogent reasons for expedition and warned against the giving of unrealistically short time estimates in order to “manipulate an earlier listing” at [25].

The court needs to consider whether a good reason for expedition has been shown. As I have already said, on an AtL, that is likely to engage the same factors as are considered in respect of adequacy of damages and balance of convenience. Further, and consistently with the decision of Fraser J, the court will always need to consider the nature and practicalities of the hearing and the allocation of court resources which similarly engages a more detailed consideration of the issues in the case. I, therefore, address the issues in the order set out in Camelot rather than taking expedition first but I turn first to a matter that permeates the arguments in this case and relates to GPI’s product which was the subject matter of its winning bid.

Although Mr Williams KC submitted that it was not clear how this issue was relevant to MAK’s opposition to the AtL, a key issue on the pleadings and in the evidence was MAK’s case that GPI’s product is not compliant with relevant regulatory requirements and that, as a result, it poses, or may pose, a risk to patient safety. Mr Williams says that this is a matter relevant only to whether there is a serious issue to be tried and he is, in my view, right to say that that is how it was addressed in the evidence of Mr Sajot. Since the issue has been conceded, it follows that the parties should resist the temptation to argue further about the merits. This point was clearly made by Coulson J in Sysmex (UK) Ltd. v Imperial College Healthcare NHS Trust [2017] EWHC 1824 (TCC) and the cases cited therein. The judge referred to the submission of counsel, derived from American Cyanamid, that it may not be improper to take account of the relative strengths of the parties’ cases in tipping the balance. He then said:

“19.

I do not consider, on an application to lift the suspension in a typical procurement case, that this is an appropriate matter for the court to investigate. Such cases are a long way from a straightforward claim for an interlocutory injunction, where a particularly good point on a substantive dispute (an admission, say, or an unequivocal contractual term in one side’s favour) might well be of assistance to the court’s consideration of the application overall. It is not appropriate to have a mini-trial in a complex procurement dispute like this. Where, as here, it is accepted that there is a serious case to be tried, then (save in exceptional circumstances) both sides should resist any further temptation to argue about the merits.

…

21.

… Accordingly, save in the exceptional circumstances where one party has some kind of simple “knock-out” point, I do not consider it appropriate as a matter of principle for the court to conduct a mini-trial or to endeavour to reach any conclusions as to the strength or weakness of one or both sides’ cases.”

For the reasons I will come to, MAK’s case in this respect does, however, seem to me to be relevant to a number of issues and, as Mr West submitted, is particularly relied on in relation to the balance of convenience. It is, therefore, convenient to start by explaining the dispute.

There was a requirement within the Specification and a pass/fail question within the technical evaluation (BECS 281) which required the system proposed to be “appropriately assessed for conformity with current regulations relating to the use of digital systems in medical or healthcare applications. This may be via a CE or UKCA mark, or other regulatory approval ….”

GPI stated that it met this requirement in the following terms:

“The software Emolife, the BECS module of the product GPIMed4.Blood, is certified as class IIB medical device in accordance with the Regulation MDR 745/2017.”

It is common ground that the system must comply with the Medical Devices Regulations 2002 (“the MDR”).

Regulation 2 (Interpretation) provides the following definition of an in vitro diagnostic medical device:

“in vitro diagnostic medical device” means a medical device which—

(a)

is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

(b)

is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

(i)

concerning a physiological or pathological state,

(ii)

concerning a congenital abnormality,

(iii)

to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

(iv)

to monitor therapeutic measures,

and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination.”

Part IV is concerned with in vitro medical devices and the interpretation regulation (Regulation 32) includes:

““accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not –

(a)

itself an in vitro diagnostic medical device;

(b)

an invasive sampling medical device; or

(c)

a medical device which is directly applied to the human body for the purpose of obtaining a specimen.”

In summary, MAK’s case is that the system is an in vitro medical diagnostic device within Regulation 2 or an accessory within Regulation 32 and that, as a result, it is required to comply with EU Regulation 2017/746 (“the IVDR”). MAK contends that GPI’s product does not comply with the IVDR as it does not have the necessary CE mark.

In the Particulars of Claim at paragraphs 48 to 54, MAK asserts that any solution that met all of the requirements in the Specification at Appendix A to the ITT would be a “medical device” as defined in the MDR. All medical devices must be registered with the Medicines and Healthcare Products Regulatory Agency (“MHRA”) before they can be placed on the market in the UK. Under post-Brexit transitional arrangements, in vitro devices compliant with the IVDR are considered compliant with the MDR and can be placed on the market until the end of June 2030. MAK then says that, given the requirements of the Specification, the software needs to function as an in vitro medical device within the scope of the IVDR and/or Part 4 of the MDR. It is said that the software is designed to be an integral part of the diagnostic process, especially transfusion compatibility and safety tests, and acts as an accessory to in vitro diagnostic devices within the terms of Article 1 of the IVDR and/or regulation 32 of the MDR, and must therefore have the same conformity assessment.

MAK’s pleaded case is that the Emolife product is not registered with the MHRA, is not compliant with the MDR and does not have the appropriate conformity marking under the IVDR. It is, therefore, MAK’s case that GPI’s tender ought to have been excluded and that it would not be lawful for the defendant to enter into a contract for the supply of a product that was not compliant with the relevant regulations.

The defendant disputes this. The defendant’s case is that a BECS is a medical device which is required to comply with the Medical Devices Regulation (EU) 2017/745 (“EU MDR”); that Emolife holds a CE-MDR certifying compliance with that Regulation; and that a BECS does not meet the criteria for an in vitro diagnostic device or an accessory thereto and was, accordingly, not required to comply with the IVDR.

Mr Richardson points out that in its pre-action correspondence, MAK did not at first contend that the ITT sought or ought to have sought an in vitro diagnostic medical device and, indeed, positively stated that GPI’s Emolife product had relevant CE-MDR and CE-IVDR certifications. Osborne Clarke’s letter dated 14 May 2015 said:

“7.1

Our client considers that it is clear that any solution that meets all of the requirements set out in the Specification at Appendix A of the ITT will be a “medical device” as defined in the Medical Devices Regulations 2002 …. Accordingly a bidder may only lawfully propose, and the Authority may only lawfully accept, a tender to provide a solution that is fully compliant with the MDR and MHRA’s requirements for a medical device.

…

7.5

… Based on our client’s market knowledge of GPI’s products and the limited feedback available, our client anticipates that GPI may have bid on the basis of its eDelphyn product.

7.6

If that is correct, our client is very concerned to note that, at the time of writing, our client understands that eDelphyn is not in compliance with the requirements to be met prior to placing a medical device on the market, as set out in the MDR. In particular, our client understands that eDelphyn does not have a CE-IVDR, CE-MDR or UKCA certification and is not registered with the MHRA.

…

7.8

… This is despite the fact that GPI holds relevant CE-MDR/CE-IVDR certifications for other products in its range (Emonet and Emolife) that offer similar functionality to eDelphyn in the EU, notably in the Italian market.”

Thereafter, the defendant explained, by letter dated 3 June 2025 that GPI had offered its Emolife product. The defendant submits that MAK’s subsequent change of position undermines the credibility of its case.

In its Defence served on 7 August 2025, the defendant averred that a BECS does not meet the criteria of an IVDR and does not need to comply with either EU Regulation 2017/746 or the MDR in this respect. It is further averred that the BECS platform does not perform any in vitro diagnostic testing and therefore compliance with the IVDR was not part of the defendant’s requirements.

Paragraph 31.5 of the Defence as later amended is as follows:

“It is further averred that those aspects of the Gpi4Med.BloodEmolife suite (the product) offered by the successful tenderer) which so interact with third party IVDR instruments, namely the WEBLAB module, are in any event covered by an appropriate CE-IVDR held by that tenderer. This is in addition to the CE-MDR held by the tenderer that covers Emolife which is the BECS module within the GPi4Med.BloodEmolife suite.”

Prior to that amendment being made, the defendant had informed the claimant by letter that the product which GPI offered was the Gpi4Med.Blood suite within which the Emolife module comprised the core BECS functionality.

In amendments to the Particulars of Claim, MAK referred to this perceived change of case and stated that, based on information in the public domain, it did not appear that Emolife was part of the Gpi4Med.Blood suite.

MAK submitted, and Mr Sajot suggested, that this amendment implied there was some confusion or lack of understanding on the part of the defendant as to what had been tendered for and what had been accepted. However, what is now set out in the Defence reflects the terms of GPI’s tender. Further, the evidence of Mr Stofella is that Emolife and eDelphyn are, in fact, names for the same product, constituting the principal software module for the BECS. The product, he states, is registered under both names and has the same CE-MDR certification. That can been seen on the face of the Bureau Veritas certificate exhibited to Mr Stofella’s statement. It is suggested by MAK that that adds to the confusion but, in my view, it goes to explain any apparent confusion and to provide a proper response to the arguments in relation to certification.

Following the original Defence, MAK made a Part 18 Request asking the defendant to explain the case that the BECS did not need to meet the criteria of the IVDR and did not need to comply with EU Regulation 2017/746 or the Medical Devices Regulations 2002 “given that the software is designed to be an integral part of the diagnostic process and acts as an accessory to in vitro diagnostic devices ….”

I do not intend to set out the Reply in its entirety but, in summary, the defendant’s response was this:

MAK responded at length to this position and expanded upon its argument in the Reply served on 25 September 2025 and in Mr Rudd-Clarke’s evidence on this application.

For completeness, there is a further issue raised on the pleadings and addressed in the evidence. The defendant says that there is a subsidiary module of GPI4Med.Blood (namely WEBLAB.MDW) which does interact with third party in vitro diagnostic medical devices and that this does hold IVDR certification. Mr Stofella states that by paragraph 7 of Article 1 of the EU MDR, the MDR governs the regulation of the entirety of the system even if a component part is governed by the IVDR.

It is accepted by the defendant that this component module was not identified in the tender and was as such not relevant to GPI’s bid, although it would be relevant to any issue of patient safety.

I have set out the nature of these issues in some detail because it makes it clear that the court cannot resolve these issues on this application. It is apparent that there are a number of layers to MAK’s argument including (i) whether the ITT required compliance with the regulatory requirements for an in vitro diagnostic device or accessory; (ii) whether the ITT ought to have done so (because a BECS falls within relevant definitions); and (iii) whether the BECS tendered by GPI is compliant. Indeed, Mr Neill submits that MAK’s argument that a contract for a product that does not comply with the IVDR conflates (i) the defendant’s statutory duties under the Blood Safety and Quality Regulations 2005 and the Health and Social Care (Quality and Engagement) (Wales) Act 2020 (referred to in the defendant’s evidence), which would be material to the implementation of the BECS, with (ii) the distinct question of compliance with the defendant’s duties under the PCR, and that it is the latter which go to the lawfulness of entering into the contract in so far as relevant on this application.

Resolving these multi-faceted issues would amount to a mini-trial and this is patently not the exceptional case which Coulson J contemplated in Sysmex or one in which there is a knock-out point. As I have said, however, this issue features elsewhere in MAK’s case and I return to it below.

MAK is, on its own evidence, a leading provider of blood management services. Its own advertising states that its software manages 1 in every 3 blood transfusions across the world and 30 million blood donations each year.

MAK’s UK accounts for the year ending 31 December 2023 contain the following statements:

“Founded in 1984, the MAK-SYSTEM brand has established a dominant position in the vein-to-vein blood management market, with more than 100 customers across 35 countries, including national blood services, major hospital networks and global pharma companies …

ePROGESA – the original blood collection management platform and largest product by revenue,. This product is the industry gold-standard for managing the blood collection, analysis and storage process, and is used by more than 20 national services globally.”

MAK’s most recent published turnover was USD 36,384,000. The evidence of Mr Richardson is that less than £190,000 was earned from the existing contract with the defendant. The new contract will be worth between £320,000 and £1.3m per year, that is between 1% and 5% of MAK’s turnover. The supplier will be responsible for managing around 100,000 blood donations each year, representing less than 0.34% of the blood collections managed by MAK each year.

On the face of it, therefore, the contract with the defendant is of somewhere between marginal and minor financial significance to MAK and damages would patently be an adequate remedy.

MAK’s argument to the contrary is principally that it will suffer reputational damage which cannot be adequately remedied in damages. It is well-established that the claimant must provide cogent or compelling evidence that it will suffer significant financial losses that are not recoverable or not adequately compensated in damages – see Bombardier Transportation UK Ltd v London Underground Ltd [2018] EWHC 2926 (TCC) at [58], Openview Security Solutions Ltd v London Borough of Merton [2015] EWHC 2694 (TCC) at [39]; and Camelot at [98].

The principles were further summarised by this court in One Medicare v NHS Northamptonshire ICB [2025] EWHC 63 (TCC) at [45]-[48]:

The evidence of Mr Sajot seeks to establish that MAK meets this high threshold and is likely to suffer reputational damage that is irremediable or not adequately compensated in damages.

Mr Sajot says that changes of supplier are unusual in this market and tend to attract the attention of other blood service authorities. MAK is known to be the BECS provider to the defendant and the loss of the contract will create a perception that it was either unwilling or unable to meet the WBS’ requirements satisfactorily which will undermine MAK’s credibility and reputation in the market.

Mr Sajot argues that NHS contracts are prestigious and have high reputational standing amongst blood services authorities in the UK and EU. Being awarded the contract would increase MAK’s chances of winning further BECS contracts particularly in the UK including a contract with NHS Scotland which is due to be re-procured within the next 12 months. He states that he is aware of further BECS contracts in England that will be re-tendered “in the coming years”. He states that winning the contract would also act as a springboard for other upcoming procurements including two in Spain and one Malta and that, without this contract, MAK’s chances of success will decrease.

Further, he says that the impact is compounded by the fact that the winning bidder is GPI which is, he says, a comparatively small provider in a niche market. If GPI were to enter into the contract with the defendant, Mr Sajot argues that this would give the misleading impression that GPI possesses a solution which is compliant with “conformity requirements”.

I accept Mr Williams’ submission that these arguments that the loss of the contract will undermine MAK’s reputation and the evidence in support fall well short of the high threshold. Mr Sajot’s evidence amounts to no more than the assertion that the loss of a contract by an incumbent provider is damaging to its reputation. It takes no account of the ability of MAK to rely on evidence of past performance of this contract with WBS or on its performance of other contracts.

Firstly, as I said above, Mr Sajot seeks to put this type of BECS contract into a special category on the basis that there are rarely changes in providers – he implies, therefore, that the loss of a contract by an incumbent provider is more significant than would commonly be the case. This sort of bald assertion needs, in my view, to be treated with caution. There is no independent evidence to support it. Mr Stofella’s evidence is that such contracts come up frequently and he states that he is aware of 5 national and 9 regional procurements for BECS in the last 3 years and that some of these related to areas with significantly greater populations than that of Wales. There is no evidence as to whether these contracts have been awarded to incumbent providers or not and with what, if any, consequences for unsuccessful bidders.

In my judgment, absent some cogent evidence and analysis from MAK as to the frequency of changes in suppliers and the impact, if any, of changes, the court should treat MAK’s assertions with circumspection and proceed on the basis that there are no special and material characteristics of BECS contracts.

Secondly, the argument as to the prestigious nature of this contract, being an NHS contract, is not sustainable. If it were right, it would lead to the conclusion that all NHS contracts were particularly prestigious and would provide a reason not to lift the suspension in any case involving an NHS contract. In any event, MAK is the current provider of NHS blood management services in Scotland and Northern Ireland. Mr Richardson gives evidence that MAK has recently secured its contract with the Northern Ireland Blood Transfusion Service and also recently secured contracts with the New Zealand Blood Service and New York Blood Centre Enterprises. Mr Richardson points out that the Pre-Qualification Questionnaire required bidders to provide evidence of experience of delivering requirements of a similar nature to the brief over the past three years. In response, MAK referred to the contracts set out above in New Zealand and New York, together with a contract in the Netherlands, but not to its other NHS contracts. In itself this militates against any argument that the present contract is particularly prestigious or significant.

It seems to me further relevant to take account of the context. MAK portrays itself and its product as the gold-standard with a global client base of over 100 clients (including 20 national blood services) in 35 countries. The contract with the WBS is a very modest one in the context of MAK’s business and market reach as a whole. Against this background, it is inherently improbable that the loss of the modest contract with the WBS will have any reputational impact at all.

The argument that damages would not be an adequate remedy for the claimant was accepted by O’Farrell J in Draeger Safety UK Ltd. v The London Fire Commissioner [2021] EWHC 2221 (TCC). There was evidence before the court that the procurement was being watched by other fire and rescue services throughout the UK. At [41], O’Farrell J concluded:

“The evidence before the court does not indicate that this procurement is unique or high value. However, it is being closely watched by a number of other fire and rescue services and is likely to be perceived as setting the standard for improved protective equipment in this sector. On that basis, it is arguable that, if the automatic suspension is lifted and Draeger is ousted from its position as the incumbent provider of breathing apparatus for LFB, it will suffer a loss for which damages are not an adequate remedy.”

In Vodafone Ltd. v Secretary of State for Foreign, Commonwealth and Development Affairs [2021] EWHC 2793 (TCC), Kerr J similarly accepted that the particular importance of a contract to the clamant might be established not by reference to the financial value of the contract. In that case, Vodafone submitted that the contract was global in its coverage and prestige and that it was, on the evidence, likely to open up other prestigious public sector contracts including some called off the same framework (at [62]). At [87] he accepted that the unquantifiable loss of opportunities to bid for and win other contracts on the back of the present one was not vague and speculative and was a reason not to confine Vodafone to its remedy in damages.

In the present case there is no evidence that this modest contract is of any particular interest to the wider market or would be regarded as setting any standard (as in Draeger); it is not global in its coverage or prestige; and the evidence that it might affect future bids is vague and speculative:

The unusual aspect of MAK’s case, and where the argument as to the regulatory compliance of GPI’s bid fits in, is the contention that GPI’s bid is non-compliant and that its success in this procurement will disadvantage MAK in future bids and/or give GPI an unfair advantage. It is unclear whether that argument is advanced generally or in contemplation that in future bids MAK will again be in competition with GPI.

The argument in itself seems to me either wrong in principle or of little weight. As I have said, in any future procurements, the commissioning authority or healthcare provider will set out its specification and requirements and make its own evaluation of compliance. The fact that GPI has won this tender on the basis of the WBS’s specification and requirements may be relied on by GPI as evidence of its experience but would not per se affect another healthcare provider’s specification or the evaluation of any bid by MAK or, indeed, GPI.

Even if that were wrong, to take account of this aspect of MAK’s case in the context of adequacy of damages as a remedy comes perilously close to asking the court not only to accept that there is a serious issue to be tried but to decide the merits. I say that because, if this alleged non-compliance and “unfair” advantage to GPI and disadvantage to MAK can be relied on as a reason that damages are not an adequate remedy for MAK, this specific aspect of MAK’s challenge would be treated differently from other aspects of challenge. That would carry with it the implication that the court ascribed to this issue some particular merit and/or that the court had some particular concern about patient safety. That would be wrong in principle.

Even if that approach were open to the court, I cannot see that this aspect of MAK’s case has any special status or merit. I will address the arguments about patient safety below but the argument in relation to regulatory compliance is, to put it neutrally, one in relation to which there are serious issues to be tried as to what was or what ought to have been required in the specification and whether what was offered was compliant. If MAK is, in due course, successful in its arguments, and can show that there is a causal connection between (i) the misconception of compliance of GPI’s product and (ii) GPI’s winning and MAK losing some future contract with another healthcare provider, that can be compensated in damages. That concerns a definable aspect of future bids and not a more general impact of loss of reputation or the wholescale re-scoring of any future bid.

It is convenient to return at this point to the application for expedition. As originally articulated, the application was for expedition of the trial of all issues. In correspondence the defendant had indicated that a trial might be fitted into a 2 week period and it appeared that such a trial would be possible in July 2026.

The defendant nonetheless opposed the application for an expedited trial. The reasons for doing so related, and relate, to the timescale for the intended implementation of the new contract services which is addressed in the evidence of Mr Richardson.

On the basis of consultation with other blood services and potential service providers, the defendant concluded that a period of 2 to 2½ years would be required from the entering into of the new contract to the new system being deployed. This period was required for safe completion of configuration, data migration, testing and validation. The ITT at paragraph 5.1.2 therefore provided for an implementation period of over 2½ years from 1 April 2025 to 30 November 2027 (“the Commencement Date”).

The ITT at paragraphs 6.8 and 6.9 required a tenderer to offer at the Commencement Date to provide Option 1, the “minimum viable product”, which would ensure delivery of a BECS solution equivalent to that currently in use. Option 2 was to provide the minimum viable product plus Patient Management (platelets) and Hospital Ordering. Option 3 was to provide Options 1 and 2 plus Appointments Management & Customer (Donor) Relationship Management.

Paragraph 6.10 provided:

“It is a requirement that Bidder’s (sic) must be able to deliver all three options detailed in paragraph 6.8 as part of their offering during the life of the Contract, however, option 1 as a minimum must be available from the Services Commencement Date ie 1^st December 2027. During the contract Implementation Period the Commissioner and Provider will agree the timescales for scheduling and implementing the additional module options and system functionality.”

GPI’s tender, however, offered full implementation of Option 1 and three of four additional modules in Options 2 and 3 from the Commencement Date. On this application, Mr Stofella’s evidence is that, based on its experience, GPI considered that an implementation period of 24 months for this offer was achievable but an additional 6 months could be required.

Delivery of the services with the new BECS was, therefore, due to commence when the MAK contract expires at the end of October 2027, although that date may already have gone out to end November (as in paragraph 6.10 of the ITT). A proportion of that implementation period has obviously already been lost and, the defendant submits, maintaining the suspension will cause further delay of many months even with an expedited trial of the whole or part of the claim.

The defendant’s position is further that delay in implementation will accordingly delay the introduction of the benefits which the defendant intends the new BECS to provide. The current software was developed between 2009 and 2015. As well as updating and future-proofing the system, Mr Richardson’s evidence, in summary, is that the benefits of the new system and the new Options will include (i) an enhanced ability to support safety; (ii) auditability and vein-to-vein traceability including efficiency in testing and production area; (iii) effective donor patient management and donor-facing services; (iv) reducing the administrative burden through the automation of routine administrative tasks; (v) enhanced stock management and demand management; (vi) improvements to the donor experience.

Taken together those are the key reasons for the defendant’s opposition to an expedited hearing.

MAK does not dispute that the new system will offer new benefits but MAK submits that the ITT demonstrates that a tenderer was only required to offer Option 1 at the Commencement Date and that the defendant is, therefore, indifferent to when the benefits of Options 2 and 3 are available. In other words even if the maintenance of the suspension might delay the Commencement Date that would have no material impact in terms of the introduction of benefits. The defendant disputes that it is indifferent to the timing of implementation of the new modules. Mr Richardson’s evidence is that the intention of the provisions of the ITT was to obtain the advice of bidders on achievable timescales based on their experience. GPI’s bid provided most of the new benefits by November 2027 and that is what the defendant wishes to achieve.

I can see that the terms of the ITT indicate that there was nothing critical about the Commencement Date in terms of the provision of new benefits by that date but it does not follow from that that the potential loss of the benefit of GPI’s ability to implement many of those enhancements at the Commencement Date is not then a relevant consideration. In this context, it is of some relevance that the implementation of the new BECS takes place against the background of the Report of the Infected Blood Inquiry. The Inquiry’s recommendations required blood services and authorities to improve transfusion practices and provide funding, which was to be regarded as a priority, for digital transformation and enhanced electronic clinical systems in relation to blood transfusion (recommendation 7(f)). The new contract is intended to respond to this recommendation and it would be perverse if the prospect of implementation earlier than might have been permitted in a compliant bid were to be discounted.

Even if there could be a two week trial of all issues in July 2026, there would inevitably be a substantial delay in implementation and that both militates against maintaining the suspension and takes away the justification for an expedited hearing.

By the time of the hearing, however, the defendant’s position was that a trial could not be accommodated in less than 4 weeks. Given the scope of the issues raised including the number of scoring challenges, the suggested 2 week estimate was to my mind always unrealistic and, although the claimant made something of the fact that this time estimate had originated with the defendant, there can be no criticism of the defendant for now putting forward a more realistic time estimate. I bear in mind the warnings of Fraser J in relation to the temptation to give inadequate estimates. Even with a 4 week estimate, there is a multitude of issues to be addressed in a short period following which the court will have to give judgment which will require substantial time to consider each of these many issues, reach decisions and formulate those decisions in writing. A judgment before the end of the summer of 2026 would be possible but improbable.

Having regard to the principles as to expedition set out above, I would not have concluded that there was any justification for an expedited hearing of the whole. The position, however, modified in the course of the hearing. Mr West proposed, as an alternative, that there should be an expedited hearing of what I have called the compliance issue; that that could be in May 2026 with a 6 day estimate; that the suspension should remain in place until that issue was decided; but, if it was decided against MAK, MAK would then accept that the suspension should be lifted.

There were two reasons advanced for adopting this approach. The first was that the swift resolution of this issue would mean, if it were decided in MAK’s favour, that MAK would not, in soon to be forthcoming tenders, suffer the perceived disadvantage from GPI’s product being wrongly regarded as compliant with the applicable regulatory regime. This argument carries little or no weight and I repeat what I have said above in relation to the specification for, and evaluation of bids, in future procurements. I observe also that it would not follow that MAK would then, and without further consideration of its claim, be able to portray itself as the successful tenderer for the WBS contract since its score placed it in third rather than second place.

The second reason is patient safety. Firstly, and at the risk of repetition, it is not appropriate on this application for the court to reach any conclusions on the compliance issue. By the same token reaching any conclusion that there was a risk to patient safety by entering into the new contract and/or by the implementation of the new BECS at the Commencement Date, such that the stay ought not to be lifted, would amount to conducting some or all of such a mini-trial. In my view, the court cannot and should not reach any such conclusion at this stage and I should, rather, have regard to the weight the court attaches to the public body’s view as to how best, in the public interest, to provide the services and benefits which it requires.

In saying that, I take into account the defendant’s submission that the evidence of Mr Rudd-Clarke and Mr Sajot falls short of evidence that there would, in fact, be any risk to patient safety if the BECS was (i) required to have a particular registration/certification and (ii) did not do so. Mr Rudd-Clarke at paragraph 34 states that the if the court were to decide in due course that GPI’s product had not been through the applicable processes to place it on the market, there may be safety implications. Mr Sajot goes further and asserts that:

“The lack of a fully compliant BECS risks incorrect donor eligibility decisions, release of components without complete testing, mislabelling or data integrity errors, inability to rapidly trace, quarantine and recall affected units, and delayed or incomplete reporting.”

There is no evidence to support this assertion and no explanation of how these risks could follow from the BECS being compliant with the EU MDR but not being treated as an in vitro diagnostic device or accessory.

On the contrary, the evidence is that to obtain the certification for Emolife, GPI was required to pass a third party assessment process with Bureau Veritas and is required to submit to continuous monitoring by Bureau Veritas including the testing procedures for any software update and yearly audits of quality systems.

Further, GPI’s product is already in use worldwide. The evidence of Mr Stofella is that GPI4Med.Blood has been implemented at a national and regional level in 45 countries, with a combined population of 300 million, and servicing 6 million donations per year. There is no evidence of any issues relating to patient safety

MAK’s Class A certification is a self-certification. On Mr Sajot’s evidence, eProgesa is the only BECS with this CE-IVDR certification. If that is right, and if this certification is necessary, it would lead to the conclusion that, at least within the EU and the UK, MAK would have no competition for the provision of BECS. Not only is that a startling proposition in general terms but it is all the more unlikely given the involvement of GPI in this market already.

For the avoidance of doubt, I repeat that it would be inappropriate to undertake a mini trial – whether in the context of whether there is a serious issue to be tried or the application for expedition – and that I consider it appropriate to follow the authorities addressed below which emphasise that the public body is best placed to decide how to deliver services and benefits. The matters set out in the preceding paragraphs, however, offer some support for that principled approach on the facts of this case.

I am, therefore, not satisfied that there is any justification for an expedited hearing of this confined issue. For the reasons already given, I regard damages as an adequate remedy for the claimant and I would lift the suspension and refuse the application for expedition. In case I am wrong about that, I consider the further American Cyanamid elements below.

For the avoidance of doubt, I add that an argument was advanced before me by MAK that in the defendant’s Defence its case was that the claimant had no entitlement in principle to damages at all and that that ought to be taken into account in considering whether damages were an adequate remedy. No such argument was advanced by Mr Williams and it seemed to me to be a misreading of the Defence. I, therefore, say no more about it.

The matters which have already been addressed above in the context of the application for expedition relating to the benefits of the new system and the delay in implementation are matters that cannot be remedied in damages for the defendant. The courts have repeatedly said that, whilst they will not consider the merits of the parties’ respective positions on benefits of the successful tenderer’s bid, it is public authorities who are best placed to assess what they consider the benefits to them to be – see Medequip Assistive Technology Ltd. v Royal Borough of Kensington and Chelsea [2022] EWHC 3293 (TCC) at [47]; One Medicare at [67]; and, most recently, SOS International Assistance UK Ltd v Secretary of State for Defence [2025] EWHC 2634 (TCC) at [51] where Eyre J said this:

“…. it will not normally be an answer to this point for a claimant to contend that the changes are not in fact material or that they do not amount to an improvement. The effect of the continuation of the suspension in circumstances such as those here is that the public body in question is being prevented for (sic) arranging for services to be provided in the form and on the terms which it wishes and which it regards as beneficial. That is a loss which cannot be compensated in damages. The point is reinforced by the fact that consideration of the balance of convenience is required unless the court is satisfied that damages will be an adequate remedy ….”

The present case is somewhat different in that there is no dispute that the new contract will bring benefits and the issue is rather one of timing but, in my judgment, the loss of opportunity to introduce those benefits within expected timescales is not a loss that can be adequately remedied in damages.

One issue then raised by MAK is the contention that its contract could readily be extended. It seems to me, firstly, that this assumes that no importance should be attached to the timing of the implementation of the new modules and, for the reasons I have given, I reject that argument.

Mr West relies on the decision in Case C-454/06 Pressetext Nachrichtenagentur GmbH v Austria ECLI:EU:C:2008:351 which it is submitted remains relevant because the current contract was procured under the PCR 2006. Following that decision, it is submitted that the current contract could be extended as (i) the extension would not introduce conditions which, had they been part of the original award procedure, would have allowed for the admission of different tenders or acceptance of a tender other than the one accepted; (ii) the extension would not change the scope of the contract to encompass services not initially covered; and (iii) if the extension continued on the same terms it would not change the economic balance of the contract in favour of MAK.

Mr Williams submits that the issue turns on Regulation 72(1)(e) of the PCR 2015 which reflects the decision in Pressetext and which provides that modifications are permitted to existing contracts if they are not “substantial”. Regulation 72(8)(d) provides that a modification is substantial if it extends the scope of the contract considerably. The defendant has already twice extended the existing contract with MAK. The defendant’s position is that there is at the least a risk that the court or another supplier would take the view that a further extension in itself or in aggregate amounted to a considerable modification and, therefore, an impermissible modification.

Whether the Pressetext principles or Regulation 72 applies, it is not possible or appropriate for the court to determine this issue as to the lawfulness of any extension on this application. It is sufficient to say that there must be a risk that any extension would be impermissible and expose the defendant to further proceedings. Even if delay were not an issue this would not be an answer to the defendant’s case that damages are not an adequate remedy for it.

For completeness, I add that there was a further argument advanced in the statement of Mr McCarthy as to the application of Regulations 72(1)(b) and paragraphs 5, 6 and 7 of Schedule 5 to the Procurement Act 2023 which he argues “could reasonably apply to a situation in which an extension of the Current Contract is necessary” or in which there could be a direct award of a further contract to MAK. The defendant disputes that each of these provisions is applicable. But, in any case, as the defendant submits, there is little comfort to the defendant in these potential arguments for the legality of a further extension of MAK’s contract. There would be a risk that a further extension or direct award of a further contract would be the subject of challenge and further litigation.

I repeat that MAK’s arguments in this respect also seem to be predicated on the assumption that delay to implementation of the new contract can be discounted as irrelevant to the loss that will have been suffered by the defendant if the defendant succeeds at trial. There is a dearth of evidence from MAK that it could, during any extension of its existing contract, provide the benefits of the new contract and avoid or mitigate that loss. Osborne Clarke has already said in its letter dated 22 September 2025 that it would take 9 months to update MAK’s current eProgesa system to the latest software. Mr Richardson then says that it would take a further 6 months to implement the new Options. There would, therefore, be a period of 15 months activity and expenditure which would be entirely wasted if the defendant were successful at trial. Although some expenditure might be quantifiable and met by an award of damages, resources would have been diverted to a wasted exercise and the implementation of the new contract would have been further delayed.

There is also a suggestion in Mr McCarthy’s evidence that the defendant could enter into a conditional or enabling contract with GPI to allow GPI to proceed with works now so that, in the event that the defendant was successful at trial, the delay in implementation would be avoided or mitigated. The argument relies on the decision of in Vodafone Ltd. v Secretary of State for Foreign, Commonwealth and Development Affairs (above) at [186] to [189]. In that case, the court decided that, within 3 months of the hearing of the application to lift, there could and should be the hearing of a preliminary issue which would be conducted on the basis of assumed facts and would be largely a paper exercise. At [186] the court considered that this course would cause the least irremediable prejudice. It does not appear that the preliminary issue would have been determinative of the dispute. Nonetheless, against that background, the court suggested, and I put it no higher than that, that the defendant might be able to enter into a conditional contract with the successful bidder, Fujitsu, which would become binding if the outcome of the preliminary issue was in the defendant’s favour. As Mr Williams submitted, in that case, the possibility of such a contract had no bearing on the application to lift and was little more than a possibility contemplated by the court to alleviate the impact on the defendant of maintaining the suspension. At [188] Kerr J noted that that the arrangement “provides only limited comfort to the defendants during the period leading up to the trial of the preliminary issue…..Fujitsumight not be willing to enter into such an agreement.”

The suggestion, if it is one, that GPI might be willing to enter into such a contract, what form that contract would take and what its legality would be is thoroughly vague. It involves multiple assumptions about what might be done with little detail or clarity. It cannot be a basis on which the court assesses the adequacy of damages as a remedy for the defendant.

Lastly, I should add that MAK submits that the court should approach with caution any arguments about the perceived urgency of implementation because of delay in making the AtL. That may be relevant to adequacy of damages and/or, as MAK submits, the balance of convenience.

The proceedings were commenced in June 2025. The defendant did not ask MAK to agree to lift the suspension until 1 September 2025. MAK’s solicitors responded on 5 September 2025. The application was issued on 10 September 2025. That, it is submitted, is not emblematic of any urgency.

I do not accept that submission. The Particulars of Claim were extremely lengthy and raised a myriad issues. I do not see that the defendant can be criticised for focussing, as Ms Holtham says it did, on the drafting of the Defence first. The summer period has an inevitable impact and the defendant is reliant on in house legal services rather than a large team from external solicitors. That the lifting of the suspension was not raised until September does not, in this case, indicate any lack of urgency and certainly not to any extent that undermines the defendant’s case on the importance of implementation or where the balance of convenience would otherwise lie. Once the lifting of the suspension had been raised, the application, supported by evidence, was issued promptly.

I add for completeness that by letter dated 3 October 2025MAK offered an undertaking as to damages conditional on the defendant’s consent to the suspension being maintained. The offer was not repeated in the event that the defendant’s application to lift the suspension was unsuccessful but Mr West confirmed that this was intended to be an unconditional offer of an undertaking in damages. No offer was made as to any damages suffered by GPI. The explanation offered for that was that none had been asked for. It is an offer that ought to have been made without the need for asking. MAK clearly has the financial wherewithal to offer appropriate undertakings. In the circumstances of this case, however, it is not necessary to rely on this as a reason to lift the suspension but it is capable of being such a reason (see One Medicare at [82]).

The court only reaches consideration of the balance of convenience if there is doubt as to the adequacy of damages for either party. In this case, it is not necessary to consider the balance of convenience. If it were, I would find that the balance of convenience was very much in favour of lifting the suspension.

The factors the court will consider are again helpfully set out in Camelot at [126]:

“When determining where the balance of convenience lies:

(i)

the court should consider how long the suspension might have to be kept in force if an expedited trial could be ordered ….;

(ii)

the court may have regard to the public interest: Alstom Transport v Eurostar … at [80];

(iii)

the court should consider the interests of the successful bidder, alongside the interests of the other parties: Openview …:

(iv)

if the factors relevant to the balance of convenience do not point in favour of one side or the other, the prudent course will usually be to preserve the status quo (or, perhaps, more accurately, the status quo ante), that is to say to lift the suspension and allow the contract to be entered into: Circle Nottingham Ltd. v NHS Rushcliffe Clinical Commissioning Group [2019] EWHC 1315 (TCC) at [16].”

For the reasons I have already given, I do not consider that an expedited trial should be ordered and, even if it were, the suspension would inevitably remain in place for many months and at least until the summer of 2026, that is, a little over a year from the Commencement Date.

There is a public interest in enabling the defendant to give effect to the contract that it wishes to enter into for the purpose of providing benefits in services and, in the present case, responding to the recommendations of the Infected Blood Inquiry.

In this context, MAK particularly relies on its case as to the regulatory non-compliance of GPI’s tender and implies that there is a risk to patient safety in proceeding with the GPI contract. It did not seem to me that Mr West went so far as to submit that this risk should be an overriding consideration such that the court should maintain the suspension even if consideration of the balance of convenience was never reached and I have explained above how I regard the argument as relevant to, or fitting in with, the prior aspects of the American Cyanamid principles and the application for expedition. In short, nothing in this argument would cause me to conclude that the balance of convenience favoured the suspension remaining in place.

Accordingly, the defendant’s application succeeds and the suspension will be lifted. The claimant’s application for an expedited trial or stage of trial is dismissed.