To ask Her Majesty’s Government how many COVID-19 lateral flow tests are awaiting approval under the Medical Devices (Coronavirus Test Device Approvals (Amendment) Regulations 2021; how many have been approved; and how many that already hold Medicines and Healthcare products Regulatory Agency approval will fall if not re-approved by the extended deadline of 28 February.
I am sorry, this is a 2.45 am hang- over. Lateral flow devices from 20 CTDA applications are currently included on the temporary protocol. If we interpret the phrase “Medicines and Healthcare products Regulatory Agency approval” as CE marking, we are currently considering proposals to ensure the continued supply and usage of tests beyond 28 February and will announce plans once a decision has been confirmed.
I am grateful for the Minister’s response despite the late hour of last night’s debate. I am concerned that the information I have is that there are still 200 tests waiting, 46 have been assessed and validated at Porton Down, and the process is not well-aligned with the MHRA processes. What is being done to bring those processes back in line? What is being done to bring forward applications from devices that provide a differential diagnosis between Covid and influenza? These are already being used in Europe, but I understand that none are available in the UK because they have been held up in the validation process.
I should perhaps start with some background on this and why we have reached the situation we are in. Her Majesty’s Government began the large-scale procurement of Covid-19 test kits at the height of the pandemic. To ensure supplies for the universal testing offer, Porton Down assesses tests offered to Government. It found that three-quarters of those offered failed to meet their stated performance in their instructions for use. For most testing technology, the manufacturer needed only to do self-assessment to meet the CE marking rules, but clearly, when they were tested, they were not meeting those standards. We considered that the current standard was insufficient and did not keep bad tests off the market. That is why we had a public consultation in April that showed strong support for a more rigorous regime. In terms of avoiding a cliff edge, as it were, if they have not been validated, we are looking at solutions.
My Lords, reports indicate that the Government are seeking to implement testing only in health care settings and for the most vulnerable people, along with stopping the requirement to self-isolate if a person has Covid-19, in the next two weeks. What evidence from SAGE and NERVTAG do the Government have to show that at present, this is in the best public health interest of the country?
My Lords, for some time I have been testing every day and use testing kits that I acquire online and pay for from the same manufacturers that the Government use to distribute free tests. Why are those tests not registerable through the Government website, so that you can get an email confirmation of a negative test? The QR codes are not recognised if you buy tests yourself.
I must say to my noble friend that I was not aware of that, and therefore I will have to go back to the department. If he could write to me about that, I will be happy to respond.
My Lords, can the Minister say how many British companies are caught in this and waiting for approval? Can he also say how many billions of pounds we have spent importing these tests from China?
I will try my best to answer the questions, but if I do not, I hope the noble Lord will accept a written response. Some 25% of approved devices are from UK manufacturers, but it is important, as a fair and neutral regulator of market access that all applicants are treated equally. The Government are working to review applications for devices submitted by the process. At the same time, while we want to make sure that the British tests are of the highest standard, we are determined to harness the power of the UK’s leading diagnostic industry. We will continue to be enormously engaged with UK manufacturers and trade bodies to support a thriving domestic diagnostic industry.
My Lords, I wish the Minister a speedy recovery. He has been working late hours and deserves our total sympathy. I wonder, however, whether he could give us some indication of how much was wasted in preferential procurement of this kind of equipment. How much has all the equipment that is now out of date and has to be destroyed cost? I do not blame him for any of it, because he has relatively recently become a Minister, but will we have some kind of inquiry into preferential procurement and the wastage of all this equipment?
It is interesting that an earlier question asked if we are looking at British-based manufacturers. We want to be very careful that there is no preference, it is all based on merit and we have tests that meet all standards. To answer the question about the wider procurement process, there was a Question last week when I gave some detailed answers about the write-down of some of the value. We bought some of that equipment at the height of the market when people were desperately trying to buy equipment all over the world. Ships were being redirected en route when people thought they were receiving goods. That is why we paid the market price at the time.
My Lords, there is still the occasionally ping heard. Can the Minister bring us up to date with how many people are still employed on Test and Trace and what the total cost has been so far?