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

The starting point here is the complexity of the contractual documentation, which offered scope for the rather different approaches of the parties.

As already noted the Contract was comprised in a number of documents. Section 5 of the Order Form and Schedule 1, clause 2, set out an order of priority for construction purposes, to apply if there was a “conflict” between different provisions:

DHSC predictably rests heavily on the terms set out in some detail in Schedule 2, which plainly signpost the applicability of the relevant legislation on medical devices, including CE marking and EN 556. Medpro however highlights the ETRD and the Key Provisions, against the backdrop of the EC Recommendation as well as the wider factual background including the crisis created by the pandemic and the DHSC’s ability to apply for a derogation. While accepting the existence and prima facie effect of the extensive references to incorporation of relevant legal standards it argued that that (i) the ETRD as the “specification”, (ii) the absence of specification for a CE mark in sections 6 and 7 of the Order Form, (iii) the reference only to EN 13795, and (iv) the absence of full (notified body) CE numbering in the photos in the Annexes means that insofar as Schedule 2 terms would require CE marking or compliance with EN 556, those provisions were not, on the true construction of the contract, part of the agreed terms.

This conflict is therefore the route to the issues identified above. As to the first of those issues, Medpro says that the same points lead to the conclusion that there was no independent contractual obligation to demonstrate a validated process.

At the same time as the existence of those issues there is significant common ground, in that Medpro accepts that on its true construction the Contract required that the gowns, when delivered, “should be sterile to a sterility assurance level (SAL) of 10^-6, i.e. that no more than one in a million gowns should not be sterile.”As explained below, on its own case what Medpro really means by this is that the gowns were required to have a SAL of 10^-6. As it put it in opening submissions: “[Medpro] accepts that it was obliged under its equivalent technical solution … to provide gowns to a SAL of 10^-6”. What is does not accept is that “there was any independent contractual obligation to demonstrate a validated process”.

This point, as to a contractual obligation to provide gowns with an SAL of 10^-6 is plainly rightly accepted. The route to contractual construction which Medpro explicitly accepts and advocates is via the ETRD. This was the document identified as “the specs” which it says it relied on. It is also the document with which Medpro had to comply pursuant to Schedule 1, clause 2.2. As noted above the ETRD made clear the SAL requirement.

It is therefore only necessary to note in passing that other routes to this same requirement could be taken, depending on the view which is taken of the contractual hierarchy of materials and what fits within it. This could be via any of the following: