UK Diagnostics Industry and Covid-19 Recovery — House of Commons, 2022-05-10
Topic: Health
James Neale Hanvey (Scottish National Party, Centre-left): I thank the hon. Gentleman for that intervention. He makes some really important points. The first point I make—and I have previously paid tribute to the chair of the Vaccine Taskforce and continue to do so—is that there were excellent strategies for the control of infection in terms of barriers, mask wearing and the like. However, a fundamental part of infection control is that we cannot pick and choose the bits we do. We have to do them all. And that has been sorely lacking when it comes to testing. It has not been robust. It has been lacklustre to say the least and it has been oversold. The hon. Gentleman’s point about the important role of diagnostics in moving the NHS forward and picking up the backlog is really important. I will touch on that very briefly at the end. This is such a huge subject that I struggle to get everything in, but the points he makes are really important In terms of where we started, Operation Moonshot was supposed to build domestic capacity, and there was, I think, genuine engagement with the industry. Certainly, from the conversations I had with industry and the UK Rapid Test Consortium, it was something they felt very keen to progress. However, it failed. I understand the challenge the Government faced and I understand the reasons why they went to the international market to secure lateral flow devices or any kind of tests. This is not about bad China or anything of that nature; fundamentally, it is about UK Government decision making and—I hate to say this, but it is true—profiteering in the sale of those devices The reliability and validity of the results of the lateral flow tests have been undermined by various different assertions. The Government’s original assertion was that "lateral flow tests are accurate and reliable and have extremely low false positive rates" and a specificity of at least 99.9%. However, leaked emails by the then Secretary of State’s advisor Ben Dyson cast doubt on that, estimating that as few as 2% to 10% of positive results may be accurate in places with low covid rates. The Government’s own evaluation, conducted by the University of Liverpool, found that lateral flow devices failed to detect two-fifths of positive PCR cases. They also missed a third of high viral load and highly infectious cases. Throughout that time, however, the Government were telling everyone that they were reliable, trustworthy tests that we could depend on. I recall one case where the daughter of a constituent had had multiple negative lateral flow tests and it was not until they insisted on getting a PCR test that they found out she was infected and that she had infected everyone around her. That was a mini-cluster that caused great concern Throughout this time, I worked with academics who have been absolutely fantastic. They wrote in the British Medical Journal and other respected journals, setting out those concerns. They are experts, but the Government at the time—I focus in particular on the then Secretary of State for Health and Social Care—did not listen to those concerns and did not modify the message. Lord Bethell said in his infamous tweet of 15 March 2021 that Omega Diagnostics and Mologic were in line for an order of 2 million lateral flow devices per week by the end of May, promising jobs and security. Those assertions did not come to fruition. Like several companies, Omega has suffered big losses and has had to make significant changes to its operations. It had to sell its Alloa site and is looking to divest its remaining infectious disease portfolio. As part of the rapid test consortium, the UK Government committed to supporting the manufacture of lateral flow devices and other diagnostic equipment On 11 February 2021, Omega announced that it had agreed a contract with the UK Government. Colin King, the then chief executive officer, said: "We are delighted to formalise our relationship with the UK Government and to utilise our lateral flow test production capacity to support the COVID-19 mass testing programme being rolled out across this country…The new financial year will see this growth opportunity realised, and will also see the full impact of COVID-19 antigen testing, and so we are likely to deliver substantial revenue growth…These are very exciting times for the business and I am delighted that we can play a part in supporting the UK Government’s national effort to control the spread of the Coronavirus." The Herald newspaper in Scotland had the headline, "Jobs boost as Scots firm Omega scoops up to £375 million government contract to produce ‘instant’ Covid tests", but none of it happened. Despite those promises, significant barriers were put in place and have continued to be erected to the domestic diagnostics sector. In the case of Omega, additional manufacturing capacity was created to meet the demands of the UK Government, but they failed to deliver on the contract and promises. Instead of substantial revenue growth, the shares in Omega Diagnostics lost more than a quarter of their value when the Government pulled the rug from underneath them Some investors have lost substantial sums of money on the back of the UK Government’s promises and announcements on Twitter by Lord Bethell. They feel utterly betrayed, and understandably so. We have a situation where the UK Government failed to meet a commitment made in full public view and are now seeking to recover the costs of the readiness preparation for that expansion from companies such as Omega, despite them doing everything that they were asked to by the Government. The UK Government distorted the market with those decisions, so will the Minister commit to reviewing the impact of them on investors and industry The other side of this issue is that the domestic diagnostics sector felt completely let down, but the Department of Health and Social Care found £3.7 billion to fast-track Innova-branded lateral flow devices with an eye-watering profit margin to middle men, taking a tiny UK firm run by a property agent and a shoe retailer from being £3,500 in debt to a £20 million profit in a year. That was all facilitated by an exceptional usage authorisation from the Medicines and Healthcare products Regulatory Agency—more on that in a moment In contrast, UK companies have had to navigate their way through and overcome additional regulatory hurdles. The situation is best summed up by the industry body, the Association of British HealthTech Industries, which called on the UK Health Security Agency "to remove the confusion and uncertainty surrounding the implementation of the Coronavirus Test Device Approvals process" The CTDA process is a hurdle that only domestic producers have to navigate. All the imported products that I have set out the problems and flaws with, from the Government’s study, have a free pass. They are not subject to CTDA; only the domestic market has to deal with that challenge. Innova and Orient Gene tests are exempted from CTDA, putting the domestic diagnostics sector at a significant disadvantage. Private feedback from the industry is that the procurement process suffers from a lack of progress, transparency and poor communication. Will the Minister say why the UK Government are purposefully disadvantaging the domestic diagnostics sector? Surely there should be a level playing field In the last Session, I asked the Government a simple and straightforward written parliamentary question: "what the (a) number and (b) proportion of (i) PPE, (ii) lateral flow tests, (iii) PCR tests and (iv) other covid-19 testing equipment are that have been manufactured by UK based companies." The response was absolutely staggering: "We are unable to provide the information requested for lateral flow device and polymerase chain reaction tests and other COVID-19 testing equipment as this information is commercially sensitive."