A company linked to the Conservative peer Michelle Mone was referred to the UK’s health products watchdog for an investigation after it allegedly presented a false document to the government when tendering for PPE contracts. The referral of the company, PPE Medpro, was described in a high court document made public this week, setting out the legal claim against the company by the Department of Health and Social Care. The DHSC is seeking the return of £122m in public money it paid for the supply of sterile surgical gowns, plus £11.6m for storing and disposing of them. It has accused PPE Medpro of delivering gowns that were not sterile, did not comply with the regulations for the production of medical devices, and could have compromised patients’ safety had they been used in the NHS. The DHSC awarded that gowns contract, and another contract worth £80.85m for the supply of face masks, to PPE Medpro within weeks of Mone approaching Conservative ministers in May 2020 offering to supply PPE through “my team in Hong Kong”. In the court document setting out its claim, the DHSC states that PPE Medpro “made multiple offers to supply different types of PPE”. The referral of the company to the Medicines and Healthcare products Regulatory Agency (MHRA) related to a different tendering process from the one that led to the DHSC granting the company the gowns contract, the legal claim states. “[PPE Medpro] was found to have supplied a test report (numbered SHAT06648491) purporting to be from an entity called Intertek, but which Intertek denied having issued. As a result, PPE Medpro was referred to the MHRA’s compliance unit for further investigation.” Intertek is a large, global, UK stock market-listed quality assurance company, which provides technical testing, inspection and safety certification services in a wide range of industries, including medical devices. PPE Medpro did not respond to a question from the Guardian this week about the DHSC’s allegation that it supplied an allegedly false document purporting to have been produced by Intertek, nor about the referral to the MHRA. Regarding the DHSC’s legal claim, the company said it refuted all the allegations, argued that the gowns it supplied did meet “correct quality standards and specification”, and said it will “rigorously defend” the court action. In a statement, Intertek said: “We are not involved in the MHRA investigation or court process. We have reviewed the reference to us in the court document and we have no further comment to make.” An MHRA spokesperson said the agency could not confirm the outcome of the referral to its compliance unit: “We are not able to provide updates regarding the state of any referrals or investigations due to the confidentiality requirements set out in the Medicines and Medical Devices Act 2021. “However, we review all information and referrals we receive and where necessary we will take appropriate regulatory action.” Mone has been under intense public and political pressure since the Guardian reported in November that leaked bank documents indicated she and her three adult children secretly received £29m originating from PPE Medpro’s profits on the government deals. Her lawyer told the Guardian at the time: “There are a number of reasons why our client cannot comment on these issues and she is under no duty to do so.” Mone has previously denied via her lawyers that she had any involvement in PPE Medpro, despite her approach to ministers in May 2020 and the Guardian reporting last year, based on leaked files, that she did appear to have been secretly involved. Her lawyer has also said she did not declare PPE Medpro on her Lords register of interests because “she did not benefit financially and was not connected to PPE Medpro in any capacity”. Lawyers for Mone did not respond to requests for comment about the DHSC’s legal claim or the purported Intertek document. PPE Medpro is the subject of an ongoing potential fraud investigation by the National Crime Agency (NCA). Lawyers for PPE Medpro have declined to comment on the NCA investigation.
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