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. Bourne said that related to the next phase of his business, when he intends to begin filling the empty test tubes with saline solution. He said he had submitted a technical file to the regulator as part of the process of gaining approval for filled vials, and expected to be on the public exemption list shortly. “We submitted technical documents to MHRA. There has been no comment and it’s now an administrative process,” he said. The industry source said they were in any event baffled as to how Hinpack could come to supply test tubes. “It is highly irregular to source from an unproven, new-to-market provider where established certified providers exist,” they said. The source added he was aware of at least one large UK-based manufacturer which believed it had capacity, experience and certification for producing vials for tests which was turned down for a government Covid contract. Another industry source told us that retrospective certification of products, if that was what had occurred here, was very unusual. Bourne’s lawyers initially denied that their client had any discussions with Hancock in relation to Covid-19 supplies. However, Bourne later conceded that he had exchanged text and email messages and had conversations with Hancock over several months – but denied they had ever involved discussion of his business interests. His lawyers said it was “untrue” Bourne was helped “in any way, commercially or operationally” by Hancock. “To suggest that our client has had political, indeed ministerial, help is to betray a deeply regrettable lack of understanding of how the supply chain works,” they said. However, it remains unclear how Bourne’s company came to be awarded the work supplying millions of vials via two distributors. He said that after contacting Hancock via WhatsApp the health secretary directed him to a DHSC website where he registered his company’s credentials. He said there was no further follow-up with Hancock. A couple of weeks later, he said he received a call from a US multinational he had never heard of, called VWR, which had a pre-existing contract with the DHSC. After weeks of negotiations, VWR contracted Bourne’s firm to begin producing medical vials.
VWR declined to answer the Guardian’s questions about how it came to contact a small company with no prior track record in medical supplies and whether it had sold on the supplies with or without CE marks. A spokesman said that VWR was trusted around the world and while it had received NHS orders for Hinpack test tubes, it had not had any recently. Since August, Hinpack has been supplying a new distributor, Alpha Laboratories, which also had a pre-existing contract with the DHSC. In a statement, Alpha Laboratories said it was aware Bourne had met Hancock but “this was irrelevant to our discussions as we were sourcing from Hinpack a price-competitive product for the NHS supply chain which fitted within our product range”. When asked whether it had supplied Hinpack vials to fulfil its NHS test-and-trace contracts, and whether they were CE marked, the distributor responded that the product it supplied the government “meets the specification of the contract in question. The final application of any products supplied by us is unknown.” Lawyers for Bourne said many UK companies had “retooled” during the pandemic, adding that the medical devices he manufactured were “by no means complicated and are well within our client’s existing skillset”. The DHSC spokesperson said there was “no evidence” to support claims that Hinpack received any preferential treatment because of Bourne’s contacts with the health secretary.