The UK’s medicines regulator has confirmed it is investigating a firm that reportedly won work linked to coronavirus testing during the pandemic.
Hinpack, a manufacturing business run by former publican Alex Bourne, partnered with a diagnostics supplier to produce specimen collection tubes and funnels for Covid-19 testing.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it was investigating allegations against Hinpack.
MHRA director of devices Graeme Tunbridge said: “We take all reports of non-compliance very seriously.
“We are currently investigating the allegations about Hinpack and will take appropriate action as necessary. Patient safety is our top priority.
“As this is an ongoing investigation we are unable to disclose further information at this time”.
Speaking to the PA news agency on Sunday night, Mr Bourne said he had heard “nothing” from the MHRA on its investigation.
He said Hinpack had weekly meetings with the agency and “they have not mentioned anything to us”.
Mr Bourne said he understood the allegations against his firm, which employs 137 people, to be that “we don’t have have adequate facilities from a health and hygiene perspective” – something he dismissed as “just not true”.
He admitted Hinpack, which used to make food and drink packaging, had never made medical devices before, but said the injection moulding technology it used could be applied to test tubes.
The firm had submitted a hundred documents, he claimed, to pass through “highly regulatory” processes, adding: “You’re allowed to go and try and we got through all the hoops. We built this thing in record time and the MHRA has approved everything.”
The Guardian reported Hinpack’s work on the Covid tests was worth around £30 million, but Mr Bourne said this figure was “incorrect”.
It is understood the Department of Health and Social Care (DHSC) does not have direct contact with Hinpack.
Hinpack’s products are supplied by a distributor, Alpha Labs, which is the company that holds the contract to provide plastic funnels and tubes for coronavirus tests.
It is also understood that Hinpack’s products were examined on an individual basis and passed through rigorous validation and regulatory reviews to ensure they were fit for purpose.
The Guardian previously reported Mr Bourne, who used to run the Cock Inn in Little Thurlow, a village in the Health Secretary’s West Suffolk constituency, contacted Matt Hancock over Whatsapp to offer his services.
Mr Hancock was asked about the work and his communications with Mr Bourne at a Downing Street press conference on December 10, where he said: “I had absolutely nothing to do with that contract.”
Mr Bourne said he had got Mr Hancock’s number from a friend to initially enquire about providing personal protective equipment (PPE) and the health secretary had told him to “go through the Government website like everybody else”.
Mr Bourne insisted he had received “no preferential treatment whatsoever”.
He claimed that following media coverage of his business he had received “death threats” and had to move his family out of his house.
“During a time of national crisis we should be drawing together not trying to score political points,” he said.
Lawyers for Mr Bourne previously told The Guardian that the medical devices Hinpack manufactures were “by no means complicated and are well within our client’s existing skillset”.
Allegations against the business were all “untrue”, the lawyers said, adding the MHRA had previously inspected and approved Hinpack’s products and working practices.
A DHSC spokesman said: “In spring, we issued ‘calls to arms’ to suppliers in multiple industries asking them to support the national effort and secure products required for Covid-19 testing which were in short supply around the world.
“Information on product requirements was shared with all suitable or potential suppliers so they could rapidly and effectively meet the supply needs of the national testing programme, which is now the largest diagnostic network in British history.
“All suppliers have to pass through a rigorous regulatory and validations process to ensure that they meet the same high quality standards.
“We continue to ensure all contracts are awarded in line with procurement regulations and transparency guidelines.”
Confirmation of the MHRA investigation comes as Mr Hancock declined to apologise after the High Court ruled the Government unlawfully failed to publish details of billions of pounds’ worth of coronavirus-related contracts.
Mr Hancock has faced calls for greater accountability after a judge said he did not publish redacted contracts in accordance with the transparency policy.
Speaking to broadcasters on Sunday, however, the Health Secretary insisted legal cases about transparency returns were “second order” to saving lives and said his officials had been working long hours to procure PPE instead.
He added he would publish what was legally required and said on average the contracts had been published “just over a fortnight later than they should have been”.