Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
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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 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.