There is mounting pressure on Matt Hancock to explain how his former neighbour was awarded about £30m-worth of work making test tubes for Covid test samples as questions arose about the safety certification of the products.
A Guardian investigation revealed last week that Alex Bourne, who used to run a pub in Hancock’s village, and had no previous experience in medical supplies, has for about six months been manufacturing tens of millions of plastic vials for Covid test kits.
However, the Department of Health and Social Care (DHSC) confirmed his products only “recently” gained certification.
Bourne first contacted Hancock to offer his services during the pandemic via WhatsApp in March. His company, Hinpack, was at the time manufacturing disposable catering items and had no experience in the highly regulated medical products sector.
Medical supplies are regulated under an EC directive which ensures they meet safety standards and requires them to be “CE” marked.
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has given emergency exemptions from the EC rules for some companies to use their products during the crisis. Hinpack does not appear on the current version of its public exemption list.
Shortly after 12pm last Friday, Bourne told the Guardian that he did not have CE marks for the empty vials he had been supplying. “The stuff I’ve been delivering since June did not require a CE mark,” he said.
Later the same day, however, a spokesperson for the DHSC said that Hinpack had received certification for its products. A government source said the products had only been approved “recently” and would be registered as such on the regulator’s website shortly. They refused to say when exactly the products were certified.
“Hinpack are not in breach of regulations,” a spokesperson said. “No products used in test and trace are used until full regulatory approval has been achieved.”
The government source said that Hinpack vials were being supplied for use in Covid test kits, but would not be sent out to the public until the full regulatory approval had been achieved. They added that all Hinpack products passed through the standard regulatory review process, including vigorous validation to make sure they were fit for purpose.
Bourne has produced as many as 2m vials a week for NHS Covid tests since June. He told the Guardian that he did not believe he needed the safety certification for supplying empty test tubes and said, at the beginning of the summer, the MHRA wrote to him confirming that. The MHRA did not respond to a request for comment.
Allan Wilson, the president of the Institute of Biomedical Sciences and a leading NHS pathologist, said all the vials his lab used were CE marked, whether empty or filled with solution. “My understanding is vials do require a CE mark,” he said. Several other industry sources also said they believed CE marks were required.
One industry source, with long experience of manufacturing and regulating medical products, said he was aware that Bourne was seeking help to secure certification for his products back in September – three months after production began.