Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
(3 years, 5 months ago)
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Lord Bethell
That the Grand Committee do consider the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021. Special attention drawn to the instrument by the Secondary Legislation Scrutiny Committee, 8th Report.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, one in three people with coronavirus show no symptoms and are potentially spreading it without knowing. Testing will remain vital to controlling and containing the spread. To do this we will need a reliable supply of high-quality tests available to everyone, giving people and businesses the confidence to be recalled to life.
We should be proud of how we have risen to the challenge of this pandemic. We have grown our national diagnostics capability dramatically, with laboratory capacity now at around 614,000 PCR tests a day. The Government have to date administered 218 million tests in total, delivering around 1.1 million a day. The UK has one of the largest testing diagnostic capabilities in the world.
We have a growing market. More than 1,000 organisations are undertaking accreditation through UKAS to deliver testing services. Tests are already available on the market and their presence is growing, from use in film and sports to huge potential markets in events and workplaces. We estimate that around 97 million LFD kits are reaching our market each week, and this is increasing.
It is therefore clear that the quality of the tests available is critical, yet I know at first hand, through our stringent procurement of tests, that more than 75% of tests that we considered failed. Some tests were up to 17% less effective than they claimed. That means that, in the real world, a highly infectious person would be significantly more likely to get a false negative. These tests do not work in the real world and can in fact harm public health, causing people to spread the disease in the false belief that they are uninfected. Bad tests will increase mortality; I will not stand by and let that happen. Even meeting the low bar of CE marking has proved too much for some. The MHRA has taken action against 80 companies, including seizing approximately 48,000 non-compliant tests.
There is clear evidence of the risk that businesses and individuals can buy tests that are, frankly, not good enough. I will not settle for low-quality CE-marked tests that manipulate their instructions for use or construct their own rigged validation. I will not have them for the NHS and I do not want them mis-sold to my fellow citizens. We must act now. I have already regulated the more mature services side of the market through accreditation, but we must close any loopholes on the goods side by regulating the quality of the tests themselves.
I know it is frustrating for the producer of any high-quality test to see its product lost in a sea of lower-performing tests, often at lower prices, as some rivals have not put in the work to assure their tests and ensure the sensitivity and specificity to be useful in the real world. We want to support businesses developing quality tests through a rigorous validation process. This will set those quality tests apart.
When we conducted a public consultation earlier this year, more than 75% of respondents agreed with the need to implement a minimum performance standard for Covid-19 tests on the UK market. Indeed, one of the consultation responses highlighted:
“Current performance claims are unreliable and can easily make use of cherry-picked data. There are no set standards for sensitivity and specificity to be evaluated against, and therefore no objective way of comparing 2 tests.”
This was also reflected in what manufacturers have told me on numerous occasions. Manufacturers welcome this legislation. Many see this as an opportunity to make the market more equitable and fairer to those who strive to deliver a good product.
A cornerstone of these regulations is the register of quality tests that they will make available to anyone in the world. It will separate the wheat from the chaff in terms of tests. Empowered by this information, individual consumers and companies will be able to make informed, prudent choices when buying kits for themselves, their families or their workforce. This will provide consumers with clear and comparable information, not the miasma of confusion that some companies exploit. Either their test meets the Government’s standards and can be sold or it does not. Any manufacturer that tries to avoid these standards will face the force of the UK’s regulatory enforcement agencies. I am not interested in burdening businesses with bureaucracy but, in return, I expect businesses to engage with the scientific process openly and honestly and, when they fail, to be candid about it.
Although some may see this as a radical intervention in the market, I am reminded of Dr John Snow, the father of epidemiology. When the evidence is clear and you need change to happen quickly, radical action is no vice; it is a virtue. The change can be as simple as removing a pump handle, as Dr Snow did to prove that the source of cholera was in London’s water supply, or acting to ensure consistent standards that bring the best of business creativity to bear for the public good.
I want people to know that the tests they buy will be as good as those they would receive under the NHS, and therefore trust the results. This will empower people to take charge and make their own decisions about managing their personal health. Our experience of the pandemic shows why we urgently need to level up the whole pathology infrastructure in our country. This legislation will not only remedy the immediate market failure but be an example of effective regulation that we can build on in future.
Freedom requires vigilance. If we are to be free of this pandemic, we need a wholesale culture shift in how we manage disease. We are reliant on one another, as fellow citizens in the shop, pub or workplace, to safeguard each other’s health. Each of us needs to take responsibility as an individual. If we feel sick, take a test. If we might have been exposed to someone who was sick, take a test. If we have been somewhere where there is now an outbreak, take a test. This legislation is about empowering people to take personal responsibility for their health and giving them quality tools that they can rely on to do so.
This regulatory regime will not achieve that legacy in isolation but it will be part of the paradigm shift in how we manage disease going forward to a more proactive testing culture. It will ensure a market that provides choice to consumers through high standards and clear information; certainty to producers through clear and consistent regulation; and lessons for government to apply to future regulations. I beg to move.
Lord Rooker (Lab) [V]
My Lords, I do not wish to be at all critical of the figures that the Minister gave in his first few sentences regarding our capacity and what we have been able to do in our laboratories. I suspect, by the way, that he has a new speechwriter, as his speech was slightly different from what I have heard from him before. The reality is that I put my name down for this debate for one simple reason: last week’s reports that the Government intend to charge for devices that are currently free on the NHS. These regulations are about tests for sale.
The eighth report from our Secondary Legislation Scrutiny Committee is a masterclass in drafting. It clearly states that the market is “overwhelmingly dominated” by free NHS tests. Paragraph 3 states that
“the Government want to support a ‘thriving private sector market for COVID-19 detection tests’”.
Paragraph 4 says that these regulations are
“for a time when privately bought tests play a more significant role”.
Well, they certainly will be when the Government start charging for NHS tests. It is a £3 billion market, after all—at least I think so, from the figures I have seen.
In April, when the tests were first brought out, we were told that handing them out—and, indeed, encouraging people to take them—was vital to getting the country back to normal. The Secondary Legislation Scrutiny Committee has been very critical of the failure to supply documentation when the regulations were laid. In at least two paragraphs of its report, the committee makes it clear that free NHS tests must continue.
It is clear that the Government want to charge for the tests. I understand that the promise—and I have made checks—was made to supply them free only until the end of next month, August. There has been no commitment to go beyond that, hence the rush to get these regulations through. Quite clearly, that is what it is all about. It is being pushed through at this last minute, a few days before the Recess, so that the Government can abandon free tests at the end of August. I realise that the Minister has come briefed on the regulations and I am asking about something extra, but let us face it: it was predictable that this would be raised. He has not taken any opportunity to say anything about the maintenance of free tests. I think that is sad because he is going to be asked that repeatedly until the Government are clear about their intentions.
My final point is a question: why do we need to buy the NHS Test and Trace kits for the lateral flow test, the one being given out by local chemists, from one of the Chinese Communist Party-approved companies? How do we know they are not made with slave labour? What kickbacks go to that corrupt political party? What efforts are being made to get them made in the UK—dare I say Europe—or, indeed, Commonwealth countries? We now have the capacity to check the tests in laboratories. Why have we not done something about manufacturing capacity? Why are we reliant—we appear to be reliant—on the fix of the Chinese industrial structure, which is controlled by the Communist Party or it cannot operate? In winding up, the Minister has the chance to be clear. I do not expect him to answer everything, but it would be useful if he would say that the Government intend to pursue free NHS tests for a period beyond the end of August. After all, that is in Recess. We will not have time to query that, as we are not back until 6 September, so that decision would be taken outwith Parliament sitting, and I do not think that would be right.
Lord Moynihan (Con)
My Lords, following on from the speech of the noble Lord, Lord Rooker, and particularly referring to the Secondary Legislation Scrutiny Committee, I shall cover a number of additional points that the committee raised and seek the Minister’s advice on them.
These are welcome regulations providing rigorous quality approval processes for all Covid-19 tests sold in the United Kingdom. It is essential that tests currently sold outside the NHS do not lead to an unregulated black market developing. As we emerge from the lockdown phase and work towards a more open market based on personal responsibility and extensive, easily available testing, confidence, clarity and a strong legal framework need to be the guidelines for all such products.
I have a number of questions for my noble friend the Minister in this context. Are the proposed minimum standards to be employed exactly the same as the standards already in place for tests used by the NHS? If not, will he set out the differences? Will the proposed mandatory processes be clear and well publicised for manufacturers of molecular and antigen tests? In particular, I am interested in the process envisaged for PCR tests since it focuses on genetic material—RNA—and is new in the mainstream pharmaceutical market. In this context, is it envisaged to widen all testing on RNA-based vaccines and medications? This area of medicine impinges on major ethical issues in an area of science that is gathering pace and that many see to have advanced 10 years or more as a result of the substantial investment made in RNA-based vaccines and medicines during the Covid period.
I invite my noble friend to follow up on the intervention by the noble Lord, Lord Rooker, regarding addressing the problems with the accuracy of lateral flow tests. They are disturbing and have rocked public confidence, with 75% not meeting the performance and quality standards of the NHS tests. If we want public support for test and trace, the whole edifice of confidence collapses if there is no confidence in the accuracy of the market-based tests whose failure in turn blurs, and indeed damages, confidence in NHS tests.
Like other noble Lords, I think timing is important. It is difficult to read these regulations and believe them to be, as described, “rapid”. As I understand the position, existing tests will continue to be available in the UK market and will be required to submit their application only by 1 September. The validation process will then have to be completed by 31 October for them to remain on the market on 1 November. That means that potentially substandard products can continue to be supplied to the market for another three months or more before these regulations take effect. It is regrettable that this approach was not considered a year ago, or very early this year at least.
Can the Minister provide an update on the recruitment process required to put the DHSC validation team on a more suitable long-term footing? When do we anticipate that it will be completed? Is £6,200 sufficient to cover the proposed costs? How many applications do the Government expect as a result of these regulations?
In closing, I note that local authority trading standards are being asked to ensure that unapproved tests are removed from sale. From my experience of the Consumer Protection Act and the many hours of debate on subsequent consumer protection legislation—as applicable to, in my case, the secondary ticket market, which trading standards are being asked to oversee—I know that one of the consistent calls from all sides of the House is to increase resources to trading standards. Trading standards are constantly subject to a regular flow of additional responsibilities generated by legislative action taken in Parliament. Is it the Government’s intention to ensure that any additional resources for these purposes will be made immediately available to trading standards? If so, what do they estimate these to be?
The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)
The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the noble Lord, Lord Lansley.
Lord Lansley (Con)
My Lords, I am grateful to my noble friend the Minister for his introduction to these regulations. I agree with the noble Lord, Lord Rooker: my noble friend has acquired a rhetorical flourish or two today.
We can see the powers that we debated on the Medicines and Medical Devices Act coming into use already. The powers in Section 15 are being used for this purpose, but my noble friend will of course recall that Section 16 related to the criteria, including the effect that any regulations made would have on the life sciences industry in the UK. The Explanatory Memorandum argues persuasively that this validation process will increase the resilience of the supply chain and may even encourage domestic suppliers. It also refers to the discount available to SMEs, which is welcome. But paragraph 12.8 of the Explanatory Memorandum says that an impact assessment would be published in time for the parliamentary debate. I could not find one yesterday or today. Will my noble friend say where it is and whether it confirms that it is the Government’s clear view that the life sciences industry and SME interests are fully protected?
There is a clear case for validation of these tests, given the reported failure rates of tests submitted for public procurement, to which my noble friend referred. We need to use lateral flow tests to support the return to school in the autumn, to enable employers to bring their staff back to their workplaces, and to counter outbreaks—in particular with large-scale surge testing—when we have achieved a lower prevalence again, which I hope will be in the late summer.
Studies including the Cochrane review, published in April, suggest that lateral flow tests will reliably confirm that someone without Covid is negative; in that sense, they have very high specificity. Where their sensitivity is concerned, they will confirm infection in someone with symptoms in an average of 72% of cases, but will on average identify the infection in asymptomatic cases only 58% of the time. Those results will vary according to the location and experience of the tester—where it is done and by whom. We need these tests to work at home and not just in the hands of healthcare professionals.
I support the regulations but I have three issues to raise. First, the tests procured by the Government will not be subject to validation because that would essentially be duplicatory, as the test approval is based on that same procurement process. But that procurement process has been used by the Government principally for the procurement of the Innova tests, which, as the noble Lord, Lord Rooker, made clear, are essentially manufactured by Xiamen Biotime Biotechnology in China. The Government, of course, had an intermediary company—Disruptive Nanotechnology, in Northampton—which, as far as I can see, was effectively a non-trading company at the end of December 2019. It is Innova Medical Group that is essentially the intermediary.
Innova is a Californian company. It is reported that it has sold 380 million tests to the Government. But on 10 June, the Food and Drug Administration issued a safety communication that the Innova rapid antigen tests should be withdrawn. Indeed, its communication suggested that the people who had them should simply throw them away. The question I come to is this: if we are confident in the Innova tests, what has been the nature of the discussions we have had with the Food and Drug Administration? My understanding is that, essentially, the Food and Drug Administration took the view that Innova was advertising the tests for use with asymptomatic people, but that they were authorised for use with those who have symptoms and that their sensitivity is greater for those with symptoms. Is that why the FDA issued its class I recall on these tests? That being the case, why did my noble friend say when he introduced the regulations that it is really important that we have tests that work for those who are asymptomatic? These tests are not sufficiently specific for those who are asymptomatic.
I know that it is a legal case, so my noble friend might hide behind his inability to speak about it, but why has Mologic, a Bedford company that has a track record, found it necessary to sue the Government in relation to their validation processes for the public procurement? What does that tell us about the validation they propose to use for this purpose?
I have two very quick other points. To put at rest the mind of the noble Lord, Lord Rooker, could my noble friend update us on the plans announced last month for Innova and Sharp packaging to build a factory in Caerphilly to produce up to a million tests a day, starting in July—this month? It is absolutely right that we should have leading medical technology companies in this country and manufacturing supply alongside them.
Thirdly, to further endorse what the noble Lord, Lord Rooker, said, could my noble friend explain what the Government’s intention is on charging for tests, particularly for employers, who will want to institute testing regimes to bring their staff back into their premises and to protect the public and their customers while doing so? They have had 18 months, in many cases, during which they have lost revenues. Should we really expect them to meet this further cost at this stage? Their taxes will sustain us in the future, but should we not now support them to get back to work? I would be grateful for my noble friend’s response.
The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)
The noble Baroness, Lady Brinton, has withdrawn, so I call the noble Lord, Lord Scriven, in her place.
Lord Scriven (LD)
My Lords, of course these Benches welcome the general thrust of the regulations—that tests should be safe and that there should be a standard across the UK. However, we also raise the same issue as a number of noble Lords, including the noble Lord, Lord Moynihan, about their timing, and ask why this is emergency legislation. I am afraid it is becoming a bit of a trend that the Government bring things through in emergency legislation. If the instrument had come through a different route in which we had a lot of time, we could have asked many of the questions that we are now asking, and improved and amended the legislation to deal with some of the issues. This is so important, because this is about testing and trying to give the country a sense of what the new normal will be.
The underlying basis of this is a significant change of public health policy. I am not aware of any other infectious disease where public health policy on testing is left purely to the market—unless the Minister can advise otherwise. There is a real issue of this being about not just market failure but the role that public health, public health professions and the public sector will play to ensure that this works.
I say that because, without being linked to the test and trace system, there is a sense that testing in itself will become not as effective as it could be. This SI assumes that public policy will be for most testing to be done outside the NHS, and possibly for a charge. So once these tests are approved and there is a standard, how do mandatory tests then get into the tracing part of test and trace? There is no legislation at present to suggest that has to happen. Employers, or particularly an individual at home, could take a test and it turn out to be positive. Coming back to what has been said many times before in the House and in Grand Committee, if people feel that they cannot afford to self-isolate, they are not going to give details about them being positive.
The question is: if this becomes predominantly a market-driven approach, done by employers and businesses bringing in customers, as the Explanatory Memorandum suggests, or by individuals at home, how does that then trigger tracing? How will it trigger a person having to inform somebody, either locally or nationally, through test and trace, that they are positive? Significantly, how will tracing then kick in to help ensure that the chains of transmission are dealt with as speedily as possible, particularly since evidence suggests that 48 hours is the maximum time before the chain continues to spread?
Regulation 39A says that the Secretary of State can make an exemption for tests coming on to the market which are not tested. In what circumstances does the Minister feel that the Secretary of State would be able to use the power under Regulation 39A? How will it be reported to Parliament or to the public, so that they know whether the test they are getting—or potentially buying—has not been through the statutory testing regime?
I want to further explore something mentioned by the noble Lords, Lord Lansley and Lord Rooker. It is to do with the Innova test and the recommendation in the email from the Food and Drug Administration, which said that this test should be thrown “in the trash”—that was the exact quote. Since it was a class I recall, I need to know what extra testing or analysis has been done by the UK Government based on what they have seen from the FDA and that recall. When was that done and what is the outcome of that testing or analysis, based on the extra evidence that has come from the FDA?
Finally, I would like to ask whether free testing will still be available on the NHS. If it is to be available, a number of questions arise. If I could have free testing on the NHS and it is not means-tested, why would I buy a test, unless certain categories of organisations will not be allowed to use the NHS test? At the moment, people going abroad are not allowed to use the free NHS test. Is it anticipated to be the same for organisations such as businesses—for their staff and for customers coming in, et cetera? What thought has been put into that?
These issues, and the others which noble Lords have raised, are important because this is a matter of public health and of how we contain the virus in the most effective way possible, while keeping people safe. I come back to my opening remark: this is not emergency legislation. It should have been laid normally before Parliament, so that we could have dealt with it and tabled amendments. I would have hoped to make this better, to keep people safe and to deal with proper testing across the UK.
Baroness Thornton (Lab)
My Lords, the importance of this SI is underlined by the decision of the Secondary Legislation Scrutiny Committee to draw the regulations to
“the special attention of the House on the grounds that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.”
The noble Lord, Lord Scriven is quite right: this is not emergency legislation. Here we are, more than a year in. It is not an emergency. However, this is a very important statutory instrument. My noble friend Lord Rooker and the noble Lord, Lord Lansley, have outlined many of the questions that need to be addressed, but I need to put the Minister on notice that, depending on his answer to this debate, I may oppose it here in the Grand Committee and take it to the Floor of the House.
I am very concerned listening to this debate. I was concerned when I made my own notes, and I am even more concerned now listening to other noble Lords. This is not just about the quality of testing; it is about the market of testing, and that is quite different. That is why the Secondary Legislation Scrutiny Committee was concerned about a major change in public policy. Putting a major change in public policy through in Grand Committee under these circumstances is probably not a good idea and does not make for good legislation.
We absolutely support a quality approval process for all Covid-19 tests in the UK. It is important that the new process is rigorous to ensure that all tests, including those for sale, meet the relevant quality standards, especially if such tests are to play a greater role in the long-term management of Covid-19. In the meantime, it is essential that free NHS tests continue to be available. This is all the more important given the rising case numbers and the Government’s insistence on going ahead with the removal of all restrictions, including the legal requirement to wear face coverings on public transport, in a week’s time.
Given the importance of reliable high-quality testing devices for the effective management of Covid-19 in the long term, can the Minister explain why the new validation process was not introduced earlier? Given that the DHSC says that as part of managing Covid in the long term the Government will want to support
“a thriving private sector market for COVID-19 detection tests to supplement and support testing led by NHS Test and Trace”
and to
“encourage the private sector to bring a number of testing products and services to market to meet the differing needs of businesses and individuals”
and provide consumer choice, how will we ensure that all the tests available will meet the minimum performance standards? According to the department, the new quality requirements introduced by this instrument
“will make the UK private testing market more competitive, as manufacturers will need to improve the accuracy and speed of their tests in order to outcompete competitors”.
Can the Minister confirm the timeframe for shifting to a private testing model? How much will these tests cost and who will bear the brunt, employers or employees? Will there be waivers or business support for vulnerable workplaces, including hospitals, care homes and schools, as well as other key workers where frequent testing is key to protecting the vulnerable and often to things such as keeping a school open? Does he agree that it is essential that free NHS tests continue to be available, given the rise in case numbers and the Government’s insistence on going ahead with opening, as I have already said?
I would like to have some more information about the August cut-off point. During the procurement of lateral flow device tests for the NHS, only 25% passed through all stages of validation including the assessment for performance and quality standards under the current regime. The 75% of the LFD tests assessed as not meeting performance or quality standards of the NHS still qualify as fit for market. The DHSC says that rapid intervention is therefore required to address this. Does rapid mean now or a year ago?
Department of Health and Social Care data showed that six out of 10 positive rapid test results at schools between 4 March and 17 March turned out to be wrong. It is therefore legitimate to ask whether the real reason that we are backing away from them is because they do not work for self-testing and do not represent value for money. What is going to happen next? The Minister needs to set out the timescale. Can he confirm that if the third-party approach is to be considered, these contracts will go out for public tender?
Does the Minister share my concern that the department’s explanation appears to suggest that less accurate tests can be of diagnostic value for the NHS if such tests are used by clinicians who are able to consider other factors and information and therefore put any tests into a wider clinical context? Finally, what extra resources will be available to local authority trading standards teams for testing enforcement activities?
Lord Bethell (Con)
My Lords, I start by assuring the noble Lord, Lord Rooker, the noble Baroness, Lady Thornton, and others that when we look at this validation SI, our overarching objective is safeguarding public health. That is the primary impact of this regulatory regime for the validation of Covid-19 tests. I think noble Lords agree that high-quality tests are essential to avoid public health risks in future.
I will just clarify one key point. When I said that 75% of tests did not meet those standards and that only 50 of the 280 we had looked at passed, I meant that we rejected and never bought the 75% and were limited to only a smaller number of suppliers. That created a bottleneck in the supply of tests, which noble Lords will remember as a terrible feature of the pandemic last year which severely inhibited the progress of our campaign against this awful virus.
The importance of tests was bitterly showcased last year because of the dangers of one person potentially causing an outbreak in the whole community. Therefore, the primary purpose of the regulatory regime we are debating today is to safeguard public health.
The UK Government are clear that we want to be a world leader in agile regulation; this will encourage businesses from the UK and elsewhere to research and manufacture tests in the UK. We need that because when the pandemic began at the beginning of last year, we had neither a domestic diagnostic industry nor institutional experience of how to assess and validate tests. Those were functions that we had to build from the ground up. This SI puts in place mechanisms for encouraging a domestic industry and the standards to assess that industry.
British manufacturers and pharmaceutical research and engineering firms have led the way as part of a global effort to combat the virus, keeping the NHS supplied with kit, tests and medicines. We engaged with them thoroughly. A consultation has been published, and I would be glad to distribute it to noble Lords. They resoundingly support these measures.
If companies do not want to improve the quality of their tests to meet our standards, they simply will not sell their tests here. I see the loss of poor-quality tests from the market as positive, as it will leave more market share for high-quality tests. That is a message I give to all those manufacturing tests that cannot make the standards.
I say to the noble Lord, Lord Rooker, who asked a number of perceptive questions about the role of free testing and the policy in this area, that reports in the press are not to be given the credibility he suggests and that we have not moved on as far as he suggests. However, it is true that we have always established the principle that the Government cannot provide every single test for every single purpose. That is for two reasons. For instance, travel is essentially a voluntary matter, and it is not right for the taxpayer to pay for tests that people take in order to conduct a voluntary matter.
The other reason is pragmatic. We will not be able to sustain or have a resilient diagnostic system in this country if the state is the only player and we have no private capacity to lean on. That was our experience last year and it damaged us greatly. Countries that had private diagnostic capacity, such as Germany, survived much better and had much more capacity to lean on. So we are looking to evolve the way we do testing in this country and I will be glad to update the House when those plans are fully formed.
In response to the noble Lord, Lord Rooker, the role of asymptomatic testing will undoubtedly evolve when a large proportion of the country is vaccinated and when vaccination greatly reduces the link between infection and hospitalisation, whereas the role of PCR testing will become more important as we move to a situation where there may be new infection. We hope that R will be below one, and these changing dynamics will have a profound effect on the provision of diagnostics.
In answer to my noble friend Lord Lansley’s questions, we are enormously engaged with UK manufacturers. We have a Make programme, with a substantial team that is fully engaged with the UK diagnostics industry. I pay testimony to SureScreen, one of the key suppliers to test and trace, for the incredibly valuable contribution that it makes to our procurement. I am grateful to all those partners that supply test and trace and the NHS with tests, but we are doing everything that we can to support the UK industry.
In reply to my noble friend Lord Moynihan, the standards are the same for the NHS as the validation for test and trace. We are trying to bring about a situation where the test you take in a test and trace or NHS capacity will be exactly the same one that you take in a private capacity.
On timing, we are moving as quickly as we can and we have heavily resourced this area. In fact, our major constraint has been our desire to take these measures through Parliament in the usual fashion. On costs, the programme currently washes its own face, but we are conscious of the pressure of costs on manufacturers and we very much hope to bring the costs down.
I completely share the sentiments of noble Lords who mentioned trading standards. It has already performed an important task in holding test distributors and service firms to account, and I am enormously grateful for its interventions in the market.
We have completed an impact statement but we are waiting for final comments from the RPC. As soon as it is available we will make the statement available to parliamentarians. We have assessed that the direct costs to business of this policy are made up of £6 million annual equivalent for the validation programme and £165 million in forgone profits for manufacturers either not applying for validation or for products that do not pass validation. As the Covid-19 diagnostic market inevitably shrinks, forgone profits fall year on year from £647 million in year 1 to £35 million in year 6.
On my noble friend Lord Lansley’s question about whether NHS tests will need to undergo validation, all tests used by NHS Test and Trace have already undergone rigorous clinical evaluation, providing confidence in their performance. The Government’s proposals aim to ensure that all tests available in the UK meet the same high standards.
My noble friend Lord Lansley asked about the sensitivity and specificity of the LFD tests, and his points were very well made. The LFD test is for infectiousness. An extremely mild infection that is not in itself infectious will not necessarily be picked up by an LFD in the same way that it will by a PCR, but that does not invalidate the effectiveness of LFDs in breaking the chains of transmission.
On the taking of tests, our experience has been that, after one or two goes, tests taken at home are just as good as those being taken by clinicians in the laboratory. In fact, it is a testament to the British public that they have been as diligent and thorough as they have been in using their swabs.
I completely understand noble Lords’ concerns about the FDA press release and its concerns about the Innova tests. I assure them that MHRA colleagues were entirely involved in the intense conversations with the FDA and have satisfied themselves that the FDA’s concerns were not applicable to the UK market. We continue to maintain the purchasing of Innova tests based on validations that we in the UK have done for ourselves.
My noble friend Lord Lansley mentioned inward investment. We really hope that many firms, both British and from overseas, will invest further in the UK. We are working hard to build up a UK diagnostics industry from relatively humble beginnings into something that is muscular, innovative and makes the very best use of UK science. I hope that I will be able to make announcements on that in the near future.
The noble Baroness, Lady Thornton, asked how the costs of tests will be regulated. The cost to the public will be governed by the marketplace. I am pleased to say that the costs have come down dramatically in the past year; it is my hope that they will continue to come down.
As we move beyond the pandemic, we must consider its legacy. After World War II, our grandparents left us the NHS as its legacy. As they turned their tools and talent against fascism, so too they turned them against disease, and they moved from the business of taking lives to saving them. In the same way, we must ensure that this greatest test of our nation since World War II leaves an equal legacy for our grandchildren. I hope that a revolution to our approach to diagnostics will be that legacy, with proactive, not reactive, healthcare and disease management. I say to the noble Baroness, Lady Thornton, that our intention is for good-quality, well-regulated Covid-19 diagnostic tests to be a small but integral part of that legacy and for us to learn lessons to support the NHS in saving lives for generations to come.
The Deputy Chairman of Committees (Lord Faulkner of Worcester) (Lab)
The Grand Committee stands adjourned until 4.35 pm. I remind Members to sanitise their desks and chairs before leaving the Room.