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.
As of 3 February 2022, 87 lateral flow devices were in the CTDA approval process, and none have been approved—
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 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, in addition to the need to improve the approval process for lateral flow tests, when can we expect to see a real plan for living well with Covid? Will this include proper provision for better sick pay, improved testing and those who are clinically vulnerable.
Clearly, the noble Baroness raises a number of important considerations for when we come up with a living with Covid strategy. At the moment, we are consulting on it to make sure that we have an appropriate strategy that covers many of the issues she referred to.
As far as I am aware, they are from other countries; I do not know the exact figure for China. The suppliers that have been chosen have passed our protocol and meet the requirements of the procurement framework. It is really important that we have a rigorous standard, given that we found that many of the tests did not meet the instructions for use, as they claimed. We want a testing regime that is not only one of the best in the world but also very well trusted, especially if we are looking at using home testing for future diagnostics to identify more diseases and viruses, rather than waiting for people to go into hospital.
My Lords, given the Prime Minister’s announcement that in a couple of weeks, people will no longer have to isolate, what can the Minister say to those who have been shielding for all this time and who are now terrified that if they go out of their door, they will meet someone who is positive, so they will have to stay at home? Are their lives not as valuable as those of the rest of us?
I am sure the noble Baroness will appreciate that you always have to get the right balance. There will be those who do not want to stay at home and who want to return as quickly as possible, and you also have to consider the wider economy. We cannot shut down the whole economy for a small section of people. What we have to do is make sure that they are looked after. I have recently seen a submission about what we are going to do in future with people who are now termed clinically vulnerable and extremely vulnerable, and we will be publishing that in detail. In fact, just recently I approved a letter to the noble Baroness, Lady Brinton.
I could bore for Britain on supply chains. It was one of the academic subjects that I looked at, globally. As we become more economically efficient and supply chains become more efficient, they become more brittle. We saw how the shops were affected by lockdown and by China, and much of the manufacturing, as part of that supply chain, started in China. Companies across the world have looked at different options. Some have looked at sourcing elsewhere; some have looked at stockpiling; some have looked at reshoring; but all those options add considerable costs to the supply chain. Some have even looked at intermediary solutions, including warehousing in cheaper countries and then bringing the goods in closer. I am very happy to go on at length to the noble Lord at any time, but not now.