CL-2022-000676 - [2025] EWHC 2486 (Comm)

Medpro was incorporated on 12 May 2020 and referred to the HPL by Baroness Mone the same day. Also that day, Richard James from the Opportunities Team of the PPE Cell took over liaison with Medpro from a colleague. Mr James was a commercial specialist with a background in procurement largely in the private sector.

In an email to Baroness Mone on 12 May, Mr James requested the contact details of Anthony Page, Director at Medpro. It was he who was at all times negotiating on behalf of Medpro (although Mr James’ evidence is that Baroness Mone remained active throughout). A telephone call between the two followed, after which Baroness Mone emailed Mr James with the contact details, CC-ing Mr Page.

Mr James replied to both, requesting to speak with Mr Page the next day, on 13 May 2020. In that same email, he listed the priority for masks, gowns and aprons, inserting a link to the required specifications: https://www.gov.uk/government/publications/technical-specifications-for-personal-protective-equipment-ppe . Mr James stated that “we do undertake steps to conduct both commercial/financial and technical due diligence before placing any orders and I can talk you through what we may require in this regard when we speak. Please note as well, that this applies to the original equipment manufacturers as well and we will look to confirm the bona fides of overseas manufacturers as well. However, for offers of substantial volumes where technical certification is of a high quality this process is highly accelerated”.

Medpro’s initial offer was made on 13 May 2020, and related to 210m Type IIR face masks to DHSC. Following a call on 13 May (which had been facilitated by Baroness Mone on the previous day), Mr James sent an email to Mr Page, asking for full company details of Medpro, “in order to get the ball rolling…Also if you are interested in adding offers for gowns and gloves, please confirm the quantities and indicative pricing and I can add these into the offering.”

Details on non-sterile gowns were duly sent. However on 17 May 2020, Mr James informed Mr Page that the details forwarded by Medpro on the offer of non-sterile gowns did not meet the technical standards, but he invited offers for other priority items such as goggles, gloves and aprons that meet the specifications.

Mr Page replied: “As you know there are a lot of traders out in the market and we are hearing a lot of horrible stories. We would love to work with the NHS so could you please explain more on what we need to do. It would be good to know why we didn't pass your technical audit on the gowns, we have been supplying this quality to the Australian Government”. There were then some exchanges to clarify the standards on non-sterile gowns – in particular as to accreditation of the factory.

Some issues were raised internally at DHSC with the recent incorporation of Medpro and the potential for conflict of interest, given Baroness Mone’s husband’s involvement. However Medpro’s willingness to contract on DHSC’s standard terms was noted as a plus point.

An order for masks was placed and in the event a contract for those was concluded on 2 June 2020. This in the event was carried out without complaint by DHSC. However, the offer of non-sterile gowns petered out since the view was forming that there was no longer a need for such gowns. By 21 May Mr James was stating he was not “aware only sterile gowns were being progressed” and queried whether, since the gowns were non-sterile, he should “stop completely or just slow down”. Mr Beard responded that they had been asked to stop as they had “enough”.

By contrast, there was an identified need for sterile gowns. This must have been communicated to Medpro (Mr Page most likely) since on 21 May 2020 he sent Mr James an email stating that Medpro could manufacture sterile gowns also, and asked for DHSC’s specifications including the quantity of gowns needed. Mr James responded enclosing “the specs.” This was a reference to the ETRD, which was sent with this email. It was therefore at this point that Medpro received the ETRD which was central to their analysis of the requirements. Mr James added he would check on the volumes required.

In an email of 2 June 2020, Mr Page told Mr James that “With regards to Sterile Gowns we have managed to secure a production slot with our joint venture factory for 50 million units”. He added that the factory “had been approved by the MHRA UK” and that the production capacity was of 500,000 units per day and delivery could be on a weekly basis.

Mr James replied asking Mr Page to send “all of the technical information through to confirm sterile status.” He asked also whether it was “the same factory as previously”. That was a reference to the factory potentially identified as the manufacturer for the non-sterile gowns. Mr James added: “If so, I can amend the submission, I think, and get it progressed quickly.”

On the same day, Mr Page replied with a link to a Dropbox folder containing comprehensive technical information relating to Medpro’s sterile gowns offer.

Mr James responded that once he had the Declaration of Conformity, then “I think the sterile gowns are good to go to Technical.”

On 3 June 2020 Mr James responded to queries from Mr Page that the offer of sterile gowns was “with the Technical Team”. He added that: “Current turnaround for Technical Appraisal is 24-48 hours, sometimes faster as they [i.e. sterile gowns] are priority items and we are doing well at clearing the backlog.” In a later update he added that “Just seen that Gowns have been allocated to a reviewer so hope that means a response today/tomorrow morning as it usually does.”

On the same day a member of Technical made an entry in Mendix:

“03/06/2020 Tech review: Not acceptable - return for further info. No declaration of conformity provided. No images of product or packaging provided.”

On 4 June 2020 Mr James emailed Mr Page that Technical was concerned inter alia about “Gowns No declaration of conformity provided. No images of product or packaging provided. Hope you can provide these by return and I'll resubmit.”

On 5 June 2020, Mr Page sent Mr James a Dropbox folder link for the sterile gowns. He added “Everything that you asked for is now in there.” He added “Do you think we will hear back today? We are desperately trying to hold this slot in our production.” Mr James replied stating “These are back in with the tech team. Their responses have been getting ever more rapid and, although they're working on skeleton staff over the weekend, I would hope to hear back shortly. I'll keep you posted and will be looking at the system regularly.”

The folder did contain photographs of gowns. However while the gowns had a CE mark, it was not a CE mark accompanied by a notified body number. As Mr Clarke was later to explain: “If the product was a sterile product, if it was a Class 1 medical device, a Class 1 sterile, it should, when marked with the CE mark, be accompanied by the notified body number. … it is perfectly acceptable for some Class 1 devices, they only have to have the CE mark, they don't need to have the notified body number as well”.

On 7 June 2020, Mr James emailed Mr Page that he had “submitted the gowns for approval and am hopeful this will come through shortly.”

On 8 June 2020, Mr Page chased Mr James again: “Any news on the …, sterile gowns …? We are really trying our best to hold this production schedule for you”. In fact, it seems that on 8 June 2020 – according to the evidence of Mr Clarke the head of the VIP team in Technical Assurance “Graeme Wilkie [of Technical] reviewed the submission and put it on hold on 8 June 2020 due to a lack of certification for EN 556-1 regarding sterility.” The Mendix entry stated: “MOD QA Tech Review: 08/06/20 - Not Accepted, On Hold. No certification for BS EN 556-1-1:2001 for terminally sterilised aspects.”

So, on 9 June 2020 Mr James emailed Mr Page that “Sterile gowns response came back just now asking for certification for EN 556-1 for terminally sterilised aspects. Can you provide this and it will then go through.”

However, it is apparent that Mr Page was unclear as to what was required and replied:

“Hi Richard,

Further to your email below are the certification requirements BS EN 13795 or AAMIPB70 and BS EN 556-1?

We are checking with our factories who all have BS EN 13795.

It is mentioned on the DHSC requirement to have the above or equivalent ISO standard.

Can you please advise what ISO number is the equivalent?

I would really appreciate if you could get back to me today as we are hoping to secure these orders.”

It should be noted that this reply indicated that Mr Page had not understood the nature of sterility or the content of the relevant standards. BS 13795 was a standard which pertained to the manufacture of gowns (both sterile and non-sterile). It had nothing to do with SAL. The other standards were, as noted, sterility standards.

Mr James responded:

“BS EN 556-1-1 is the standard for sterilisation and so is needed in addition to BS EN 13795 for sterile gowns. The wording in the specifications is “or equivalent technical solutions”. This would require you to submit the details of what your manufacturer considers an equivalent technical solution and we would then apply for a derogation to BS EN 556-1-1. This would be a more lengthy process so I wouldn’t recommend this course of action. Hope that helps.”

Later that same day Mr Page emailed Mr James with “the MHRA certificate of free sale for isolation surgical gowns from the relevant factory we submitted [in respect of the Wujiang Factory]. The factory is currently suppling [sic] the EU and the UK for sterile gowns. Can you please let me know ASAP”. Again Mr Page’s lack of understanding is manifest: this certificate of free sale on its face related to “isolation surgical gowns” i.e. not sterile gowns. Not having received a reply, Mr Page emailed Mr James, querying: “… do you require anything further? Do you think we will get the gowns passed technical now?”

Mr James told Mr Page: “We're still awaiting the BS EN 556-1, I think.”

Mr Page answered later on 9 June 2020 by providing a screen shot from a slightly different version of the ETRD (not the one he had been sent) saying: “Please see the attached. We should be 100% now approved with the certificate that we sent your earlier, please also see attached. It basically either EN 13795 or 556-1. We have EN 13795 so our sterile gowns are good to go! I hope tomorrow will be better news getting this over the line.”

The screenshot was of a table with technical requirements for non-sterile and sterile surgical gowns. There was a hand drawn circle around the requirement for the latter, which suggested that a supplier of sterile surgical gowns had to comply either with BS EN 13795-1:2019 or AAMI PB70 (US standard) (all levels accepted or equivalent) and EN 556-1. The screenshot also stated that the gowns must “have a clear CE Mark”.

Shortly after, Mr James responded that “We seem to be looking at subtly different variations of the spec. This is what is on the govuk website”. He attached a screenshot from the gov.uk website (attaching a screenshot of the PDF “Essential Technical Specifications_5.pdf”.). He went on to say: “The Technical Team have specifically asked for this. If you can point me at where the documentation provided confirms the SAL then I will be able to explain this to them and hopefully get it over the line.”

Mr Page provided no such certification documentation. It is common ground that EN 556 certification was never provided. Mr Page responded that: “We are certain that we are 100% compliant. I will email you more information tomorrow.”

On 10 June 2020, Mr Page wrote:

“Please see the attached certificate. These guys sterilise for our factory which shows iso11137.

This is the indication of SAL 10.

Hopefully this is all your technical department requires.”

The document he sent through was a certificate from a German certification body, TÜV SÜD Product Service GmbH, for Wuxi Futeng Irradiation Technology Co. Ltd. That was a certification in respect of (i) page 1: EN ISO 13485 (see above – not relevant); (ii) EN ISO 11137-1:2015 “Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013).” In other words, as explained above, it demonstrated certification of a process for sterilisation. It said nothing about Part 2 of ISO 11137, nor about achieving SAL 10^-6.

Mr James replied: “Thanks Anthony, I’ve actioned it right away and will monitor throughout the day”

Mr Page continued to chase asking for news, and how long it would be. Later that day Rachel Camiss, a member of the PPE Cell, working in Supply Chain PPE Sourcing and COVID-19 Emergency Supply Chain Response PPE Sourcing sent an email titled “Urgent VIP TA Review FAO Gary/Billy SUB MXID 15012 PPE Medpro Limited Gowns” with high importance to Mr Clarke escalating the project and requesting support in looking into this the same day because “the supplier has a [tendency] to escalate to the private offices”.

Also on 12 June Mr James was chasing on an apparently separate submission numbered 19368 saying the supplier said he could not hold stock much longer. The reply from Mr Smith was “Tech assurance have placed this on hold as we require images of the product and packaging on offer. These images need to show all sides of the product carton and any instructions for use so that we can determine if the labelling meets the Gov.uk NHS requirements. This includes the required CE mark and manufacturers name and address. Please note that the rest of the submission has already been reviewed and is acceptable.”

This was passed on to Mr Page: “Latest news from the Tech team: The submission is still on hold as we believe that the NHS requirements on labelling are not met and as such would require derogation from the UK regulatory authority MHRA.We are preparing a derogation request to try and have this requirement waived”. There was however no evidence of such a derogation request ever having been submitted for the gowns which are the subject of this claim.

Meanwhile Mr Clarke was considering the documents submitted. He checked the authenticity of the Certificate of Free Sale with the MHRA satisfying himself that WTT was legitimate. Having looked at the images submitted, including the CE mark (without notified body number) he formed the view that Medpro understood the requirements of sterility and thought, with the ISO 11137 certification and the picture of the CE mark there was sufficient evidence that the manufacturer could comply with ETRD requirements. It was for him to satisfy himself that there was a valid CE mark. He accepted in cross examination that he was mistaken to form the view that this was a valid CE mark for this product. He did not submit a derogation request.

Then about 2 hours later, Mr Clarke sent an email to inter alia Mr James. The subject line read “RE: Urgent VIP TA Review FAO Billy/Gary SUB MXID 15012 PPE Medpro Limited Gowns – ACCEPT”. Mr Clarke wrote: “… Medpro Gowns submission has now been approved in Mendix.”

The Mendix entry states:

“MoD Tech Assurance Review – 12/06/2020 - ACCEPT

Confirmation received from MHRA that products may have CE mark affixed. "Certificate of Free Sale for Exportation" (MHRA ref: Certificate number: […]”

The good news was passed on to Mr Page by Mr James in an email with the subject line: “Gowns have been approved by Technical!” This message is at the heart of Medpro’s case.