PPE MEDPRO legal battle exacerbates civil servants’ recognition of “mistakes” for sterile gowns
On the second day of the £122 million high court showdown between PPE MEDPRO and the Department of Health and Social Care (DHSC), two major civil servants were questioned seriously, exposing contradictions, chaos and supervision in the government’s emergency PPE PRECUREMENT PROCURENT PROCURENT.
Richard James, a Cabinet Office official who worked at the “PPE Cell” in the Covid-ers era in DHSC, was the first to provide evidence. He confirmed that he sent an email to PPE MedPro in June 2020 saying that its sterile surgical gown had been technically approved, referring to the government’s internal technical assurance team. The approval was a key turning point, allowing the controversial supplier’s £122 million order to proceed.
But in doubt, James acknowledged that PPE MedPro never provided the certification required for EN 556-1 (European European Standard for Terminating Sterilization of Medical Equipment) nor did it carry the accompanying notification agency (NB) numbered CE marking, which is required under medical equipment regulations.
James said in response to this challenge that the approval was granted based on “ability to meet technical standards” and was not necessarily fully compliant at the time. The files provided by PPE MEDPRO have been uploaded to the government’s Mendix platform, and the technical assurance team remotely evaluated their suitability without physical access to the products made in China during the pandemic’s global supply chain chaos.
Referring repeatedly to the Basic Tech Requirements Document (ETRD) that allows for “equivalent technical solutions” during the pandemic if the product does not meet the usual standards. PPE Medpro later noted in a submission that the clause was working, although James’ email indicated that he continued to require EN 556-1 compliance until the end.
The court then heard from William Clarke, a senior member of the technical assurance team, whose role was to review the proposed sterilization certificate from PPE MedPro. Clark admitted that he admitted in questioning that he had mistakenly approved the submission without finding a body number notified next to CE Mark, a key requirement for Class I sterile medical equipment.
Clark told the court: “I should have found it. [Essential Technical Specification]As he claimed in his signed witness statement.
Clark further acknowledged that PPE MEDPRO never offered certification with EN 556-1 compliance and admitted that he relied in part on a free sales certificate issued by the UK drug regulator MHRA. It is worth noting, however, that he also said that at the time he “didn’t know what a free proof of sales was” and that it still cannot explain its meaning except that it is “effective”.
The hearing revealed that the decision to contracts worth hundreds of millions of dollars was based on fast-moving email exchanges, assumptions about technical standards, and decisions to documents that are often incomplete or misunderstood.
Clarke once told the court that he believed that the sterilization certificate of ISO 11137 (radiation sterilization standard) was sufficient to meet EN 556-1. However, when questioned, he acknowledged that ISO 11137 does not include the 10⁻⁶ sterile assurance level (SAL) required for EN 556-1. “Not at all,” Clark finally agreed.
Meanwhile, PPE MedPro’s representative Anthony Page repeatedly shows signs of confusion in emails, misreading the specification and mistakenly thinking that the standard is EN 13795 or EN 556, rather than both. Both James and Clark confirmed that this misunderstanding persisted throughout their communication.
The court exchange drew a picture of a procurement system flooded by urgency, depending on rapid decision making and stretching resources. James admits he often provides guidance to suppliers like PPE MedPro based on conversations with his technical colleagues, rather than his own expertise.
Although the DHSC case was partly dependent on claims of invalid marking and lack of infertility, both witnesses in the department acknowledged that the PPE MedPro’s documents never contained proof that met the relevant EN 556-1 standards, but were approved.
Clark’s testimony seems to support the broader defense of PPE Medpro – it was a sincere action and was allowed to continue as DHSC officials signed its documents. But as the trial unfolds, he candidly admits that he made a “mistake”, which may be key.
The hearing continued on Monday.
