The second day of the £122 million High Court case between PPE Medpro and the Department of Health and Social Care (DHSC) saw rigorous cross-examination of two civil servants, revealing contradictions, confusion, and admissions of oversight in the government’s emergency PPE procurement process.
Richard James, an official from the Cabinet Office who was part of the DHSC’s Covid-era ‘PPE Cell’, first provided evidence. He confirmed emailing PPE Medpro in June 2020 to state their sterile surgical gowns had been “approved by Technical”, referring to the government’s internal Technical Assurance team. This approval was crucial for the contentious £122 million order to move forward.
However, during questioning, James admitted that PPE Medpro had not supplied certification required under EN 556-1, the European standard for terminally sterilised medical devices, nor a CE mark with a Notified Body (NB) number, typically necessary under medical device regulations.
When challenged, James indicated that approvals were based on a “capability to meet the technical standards” rather than full compliance at that time. PPE Medpro’s documents were uploaded to the government’s Mendix platform, assessed remotely by the Technical Assurance team without physical product access, as manufacturing was in China amid global supply chain disruptions.
The Essential Technical Requirements Document (ETRD) allowed “equivalent technical solutions” if a product couldn’t meet standard regulations during the pandemic. PPE Medpro argued they operated under this clause, though James’s emails showed he consistently requested EN 556-1 compliance.
The court also heard from William Clarke of the Technical Assurance team, who reviewed PPE Medpro’s sterilisation credentials. Clarke admitted to approving the submission without noticing the absence of a Notified Body number adjacent to the CE mark, vital for Class I sterile medical devices.
“I should have spotted it,” Clarke admitted, conceding that his review was flawed and that PPE Medpro’s submission “did not evidence the requirements in the ETS” as he claimed in his witness statement.
Under further questioning, Clarke accepted PPE Medpro never provided certification for EN 556-1 conformity and confessed reliance, in part, on a Certificate of Free Sale from the MHRA, the UK’s medicines regulator. However, he admitted unfamiliarity with the Certificate’s significance, beyond it looking “valid”.
The hearings exposed how contract decisions worth hundreds of millions relied on swift email exchanges, assumptions about standards, and often incomplete or misunderstood documentation.
Clarke mistakenly believed an ISO 11137 certificate sufficed for EN 556-1. When questioned, he admitted ISO 11137 lacks the sterility assurance level (SAL) of 10⁻⁶ required under EN 556-1.
Meanwhile, PPE Medpro’s Anthony Page showed confusion in emails, misinterpreting specifications as either EN 13795 or EN 556 rather than both. This misunderstanding persisted, as confirmed by both James and Clarke.
Courtroom exchanges depicted a procurement system stressed by urgency, reliant on rapid decisions and limited resources. James admitted frequently providing supplier guidance based on technical colleague conversations rather than his expertise.
While the DHSC case mentions invalid CE marking and sterility issues, both department witnesses conceded PPE Medpro’s documentation omitted proof of EN 556-1 compliance, yet approval proceeded.
Clarke’s testimony may bolster PPE Medpro’s defence — that they acted in good faith under DHSC authorisation. However, his admission of a “mistake” in approving the submission might be pivotal as the trial progresses.
The hearing resumes on Monday.
Read more: [PPE Medpro legal battle intensifies as civil servant admits approval ‘mistake’ over sterile gowns](https://bmmagazine.co.uk/news/ppe-medpro-day-two-court-case/)
