On the second day of the High Court Showdowns of 122 million pounds between PPE Medpro and the Department of Health and Social Care (DHSC), intensive cross -interpretation of two important civil servants, which included contradictions, confusion and supervisory recordings in the government’s emergency procedure.
Richard James, an official of the cabinet office who worked in the “PPE cell” of the DHSC Covid era, was the first evidence. He confirmed that in June 2020 he had sent PPE MedPro by e -mail to say that the sterile surgical dresses were “technically approved”, which refers to the government’s internal technical insurance team. This approval was an important turning point that made it possible for the progress of the controversial supplier £ 122 million.
However, James admitted that PPE MedPro had never delivered the certification required below 556-1-of the European standard for death-stilized medical device and not a CE brand with an accompanying notification number (NB), which is generally necessary in accordance with the provisions for medical devices.
As James, James said that the permits were based on a “ability to meet the technical standards” and not necessarily be fully excluded at this point. The documents provided by PPE MedPro were uploaded to the government’s Mendix platform, and the technical insurance team evaluated their appropriate appropriateness without physical access to the products that were produced during the global chaos of the pandemic supply chain in China.
Repeated references were made on the document of the essential technical requirements (ETRD), which enabled “equivalent technical solutions” during the pandemic if a product could not meet the usual standards. PPE MedPro later argued in the submissions that it operated on this clause, although James’ emails indicated that he continued to apply for compliance with EN 556-1 until the end.
The court then heard from William Clarke, a high -ranking member of the technical insurance team, whose task was to check the sterilization registration information from the PPE MedPro offer. Clarke admitted that he had incorrectly approved the submission without recognizing the lack of a notified body number next to the CE brand – an important requirement for sterile medical devices I.
“I should have discovered it,” Clarke told the court and assumed that his review was incorrect and admitted that the submission of PPE Medpro “did not demonstrate the requirements in the ETS (essential technical specification),” as claimed in his signed declaration of witness.
Clarke also advocated that PPE Medpro never provided certification with EN 556-1 with certification, and admitted that he had partially rely on a certificate of free sales certificate published by the MHRA, the British medication regulatory authority. Remarkably, he also said that he did not know what a certificate for free sale at the time was and could still not explain its meaning when it was “valid”.
The hearings were based on how decisions about contracts with hundreds of millions of millions were based on the fast-moving exchange of emails, assumptions about technical standards and documentation, which were often incomplete or misunderstood.
At one point, Clarke told the court that he was a sterilization certificate for ISO 11137 (a radiation sterilization standard) for EN 556-1. During the survey, he admitted that ISO 11137 does not contain the Sterility Assurance Level (SAL) of 10⁻⁶, which is required under EN 556-1. “Not at all,” Clarke finally agreed.
In the meantime, Anthony Page, representative of PPE Medpro, repeatedly showed signs of confusion in e -mails, misunderstood the specification and incorrectly thinks that the standards were either EN 13795 or EN 556 as both. James and Clarke both confirmed that this misunderstanding existed during their exchange.
The exchange of the courtroom painted a picture of a procurement system that was overwhelmed by urgency, depending on fast decisions and stretched resources. James admitted that he often gave suppliers such as PPE Medro, based on discussions with technical colleagues and not on his own specialist knowledge.
Although the case of DHSC is partly based on claims of invalid CE marking and a lack of sterility, both witnesses of the department admitted that the documentation of PPE MedPRO never contained the detection of compliance with the corresponding EN 556-1 standard and was yet given approval.
Clarkes testimony seemed to support the broader defense of PPE Medpro – that it had acted in good faith and was allowed to proceed because DHSC was signed in his documentation. His open admission that he made a “mistake” to approve the submission could prove crucial if the process is settled.
The hearing will continue on Monday.