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

Volume 814: debated on Tuesday 20 July 2021

Motion to Approve

Moved by

That the draft Regulations laid before the House on 17 June be approved.

Relevant document: 8th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument). Considered in Grand Committee on 12 July.

Moved by

At the end to insert “that this House welcomes that the draft Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 introduce a quality approval process for all COVID-19 tests sold in the UK; but regrets that the regulations assume a change in policy by not making guaranteed provision for the continuation of free NHS COVID-19 tests and will therefore rely on private sector testing for which fees are charged; further regrets that private sector tests do not appear to be integrated with the NHS test and trace system, including legal requirements to report and self-isolate; notes with concern that Her Majesty’s Government have previously stated that regular testing is an essential part of the easing of coronavirus restrictions; and calls on Her Majesty’s Government to guarantee that reliable, high-quality, free NHS tests remain available to all beyond 19 July to support the effective management of COVID-19.”

My Lords, noble Lords who have read the record of the debate on this SI in Grand Committee will not be surprised that this regret amendment has been brought to the House today, given the Minister’s inability to answer the questions posed by noble Lords or indeed to reassure us over our concerns. Since then, we have had a weekend of further chaos on testing, tracing and isolating, which we will discuss tomorrow when the House takes the latest Statement on the matter. I understand that it is the 49th such Statement; it is certainly the 49th in the Commons.

For complete clarity, as the amendment states, I say that we on these Benches are in favour of guaranteeing and improving the quality of Covid tests. We also recognise that the private sector has a role to play in providing tests for those who wish to travel abroad on holiday and for business purposes. My amendment highlights the issues that were of concern to the Grand Committee and which prompted many questions, based not least on the excellent report from the SLSC, that I am afraid went unanswered.

I thank the Minister for his letter yesterday, which provided much-needed clarity on some of the issues raised and contained the kind of details that would have been helpful in last week’s debate. These regulations are not being introduced with the urgency characteristic of previous points in the pandemic, and they must be introduced and debated in a considered fashion.

This is a public health pandemic and surely no barrier, particularly a financial one, must be put in place that hinders testing and tracing, yet there has been deep unease that lateral flow tests were guaranteed to be free only until the end of July and that people could subsequently be charged under plans being considered by the Government. The Minister’s letter includes welcome confirmation that free NHS tests and universal testing will continue until the end of September. That raises the question of why the Minister could not give us that answer last week in Grand Committee. He should have been well prepared for it given the public interest, media reports and indeed the SLSC report on this instrument, which specifically raised concerns about changing policy and recommended that free testing continue. Can he confirm when that decision was made and when it will next be reviewed?

The noble Lord, Lord Scriven, asked some thoughtful questions about the supply of tests and their reliability. He asked the Minister to explain the Government’s intention on charging for tests, particularly for employers who want to institute testing regimes to bring their staff back into their premises and to protect the public and their customers while doing so. He eloquently made the point that businesses have lost significant revenue over the last week and have asked whether it is right to expect them to meet further costs at this stage. Since April, companies have been able to order rapid lateral flow tests for their workers. While we now know that individuals can still claim free tests through the NHS, at least until the end of September, there seems to be confusion as to whether the scheme for companies has closed. The Government’s website says the cut off for new orders was 19 July—the UK Government’s freedom day in England—as the requirement for masks and social distancing ended. Can the Minister confirm whether the scheme for businesses will also run until September? Does he agree that responsible employers who are ensuring their workers are regularly undertaking lateral flow tests should be congratulated on their approach rather than suddenly being asked to source tests from a private provider, which would dramatically increase costs?

My noble friend Lord Rooker, the noble Lord, Lord Moynihan, and the noble Lord, Lord Lansley, all raised the issue of the missing impact assessment, which the Explanatory Memorandum said would be published in time for the parliamentary debate, which was on Monday 12 July. Again, the Minister failed to answer this question during Committee, but his letter of 19 July reveals that the impact assessment has been red-rated by the independent Regulatory Policy Committee and withheld. Noble Lords will be aware that red-rated impact assessments are deemed not fit for purpose. This is deeply concerning. In his letter, the Minister further committed to publishing the impact assessment as it currently stands and a supporting statement “shortly”, and therefore before the parliamentary vote, following the opinion of the RPC, outlining the areas where further improvements can be made. Here we are, over a week later, about to vote—possibly—yet this important documentation has still not been published. Can the Minister explain why this has not happened, despite his assurance? Where does the buck stop for this latest failing?

Finally, the noble Lord, Lord Scriven, and I are very concerned about the seeming lack of link between test and trace and the proposed new private testing regime. While the noble Lord’s letter to me notes that it is

“vital that we introduce a regulatory regime to ensure COVID-19 tests available on the market are of sufficient quality and produce accurate results”,

it does not offer assurance in detail about how this regime and the NHS Test and Trace will work together to provide a comprehensive safe regime that the UK can depend upon. I sincerely hope that the Minister can provide some much-needed clarity.

There are many matters to regret here: the impact, or lack of it, the policy changes, the process and the timeliness. This was not an urgent matter, the Minister said. It could have been done over a month or so, and it would have definitely benefited from that. I beg to move.

My Lords, I am very glad to support my noble friend in her Motion. I want to put two points to the Minister. The context of this SI is the poor quality of many tests. Paragraph 7.2 of the Explanatory Memorandum makes the point that, during public procurement of lateral flow tests for the NHS,

“only 25% passed through all stages of validation including assessments of performance and quality standards.”

That is a pretty shocking statistic. Can I take it that most of these tests came from China? We had an Oral Question on this from the noble Lord, Lord Alton, only a few minutes ago. That being so, can the Minister assure me that Uighur slave labour in Xinjiang was not used in the manufacture of those tests?

I want to go on to the issue of poor-quality tests in general. In Grand Committee, the Minister said he would not settle for low-quality CE-marked tests that manipulated their instructions for use or constructed their own rigged validation. This, of course, is a very interesting insight into the way that devices are regulated at the moment, through the current CE marking process. In relation to most Covid-19 tests, this essentially involves a self-certification process, in which manufacturers affirm that their products meet the relevant standard. Many of the CE-marked products that have been reviewed previously have had insufficient or poor data sets that do not accurately reflect how a test product performs. This data and evidence do not facilitate accurate assessment of the product by the end-user and can be misleading.

This seems to me to raise two points. First, we should do everything we can to ensure the manufacture of high-quality tests in this country, rather than rely on imports from countries whose human rights record is nothing but utterly deplorable. Secondly, it must call into question the whole future of CE marking. I want to ask the Minister whether we can take the action being taken by the Government—essentially applying their own standards to these tests, because the current CE marking is not sufficient—as a precedent for the future. Does it lay the foundations for a new regime in relation to the regulation of medical devices?

I thank the noble Baroness, Lady Thornton, for giving us the opportunity to have a discussion around this; I will support her amendment. I am very pleased to follow the noble Lord, Lord Hunt of Kings Heath, and to echo some of his remarks and questions.

In doing so, I return to a Question that I put during Oral Questions, in an earlier part of our proceedings today, where I specifically asked about the number of lateral flow tests that have been produced and where they have come from. My interest in this originated during a hearing of the International Relations and Defence Select Committee, when were told by a witness that he was delighted that a package had arrived at his home containing a lateral flow test and that it had originated in China. This prompted me to ask a Written Question about how many of these tests had been produced in the People’s Republic of China. The Answer I was given was staggering: we had bought not 100,000 or 1 million, but 1 billion. I also asked, in that same Question, two other things: how much this had cost British taxpayers and which companies, both British and Chinese, were involved in these deals. I did not get an answer to the second two parts of my Question, so I tabled a further Written Question, asking again. It stands on our Order Paper today as having the greatest longevity of any unanswered Written Question. It was tabled on 12 May and it was due to be answered by 26 May; it is now 20 July. It is grossly discourteous to the House for Written Questions not to be answered in this way—it would have maybe saved the Oral Question having to be asked earlier on.

At the heart of that Question is the issue of due diligence. I echo something that the noble Baroness, Lady Smith of Newnham, asked during our earlier exchanges. The duty is on the Government, not on individuals, to ascertain, as the purchaser of these lateral flow tests, what the supply chain transparency is. I should mention two things here: I am a vice-chair of the All-Party Group on Uyghurs and I have a Private Member’s Bill before your Lordships’ House on supply chain transparency. What due diligence has been done in establishing the provenance of these lateral flow tests, and why have we not had answers? Perhaps the Minister can give the answers to us now. Who are the companies that have been involved in the purchasing of these tests and what has been the cost overall?

I would also like to ask the Minister something that was put to him on 12 July by the noble Lord, Lord Rooker, in Grand Committee. It is always a pleasure to find myself on the same side of arguments as the noble Lord, Lord Rooker. When I took my seat in another place, over 40 years ago, it was the noble Lord, then as Jeff Rooker MP, who welcomed me; I am glad he has lost none of his bite.

The noble Lord asked the noble Lord, Lord Bethell— I read the Minister’s reply and he did not appear to answer him in that debate, so I simply reiterate the noble Lord’s 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?”—[Official Report, 12/7/21; col. GC 430.]

That is at the heart of this question and of the debate today. It is not a trivial issue. One billion of these tests have been purchased by the UK. Just think what the costs of that will be: if it is 50p a time, that is half a billion pounds; if £1 a time, that is £1 billion. We have a right to know.

This is a point that the noble Baroness made in her remarks earlier: there needs to be not just due diligence but transparency. As far as I am concerned, there has not been sufficient transparency. We are right to press on this, just as it was right earlier to raise the issue of Hikvision. These are cameras that have been put up in our town centres and high streets all over this country, in NHS hospitals and in schools, and they are manufactured in Xinjiang. They are the same cameras being used to monitor Uighur people, 1 million of whom are incarcerated in camps. That company has been banned in the US but not here, and I would be keen to hear from the Minister what the Government—because he will be speaking for the whole Government—are doing to enforce such a ban in the UK.

My Lords, we on these Benches support the principle of this SI. Of course we want to see a mandatory standard for tests. I do not think anyone who spoke in Grand Committee argued against the principle of the SI, but there are concerns about a few issues in it. The Minister replied to the issues raised in Grand Committee with soothing words rather than convincing answers, hence the noble Baroness, Lady Thornton, has tabled her amendment to the Motion today.

I want to raise a few of the issues that the Minister either ignored by not answering or used soothing words about but did not give convincing answers to. The first question is: if we are to have a mandatory standard for tests, why have we got new Clause 39A, which is an exemption from the mandatory tests and standards that can be applied at the stroke of a ministerial pen? What is the point of having a mandatory standard for safety if the Secretary of State, at the stroke of his or her pen, can decide to do away with that? In what circumstances and for what reasons would the Secretary of State wish to bring in tests that would lower the mandatory standard, and how would the public know that they were purchasing a test that did not meet the statutory standard that had been set?

I want to address the issue of openness and transparency, as raised by the noble Lord, Lord Alton, and the noble Baroness, Lady Thornton, regarding the validity of the standard of the test as well as human rights issues. Where is the research in public on the validity of the standard of the lateral flow tests, particularly the one from China brought in via Innova, the main intermediary for a Chinese company? This test, as raised in Grand Committee, was given a class I notice in America, and an FDA email says it is not effective and gives the instruction:

“Destroy the tests by placing them in the trash”.

That is the same lateral flow test bought for billions of pounds by the UK. Again, there were soothing words from the Minister in Grand Committee about this: he said that the Government were working with the FDA. That might be true but having two differing positions— the Government saying that the test is safe while the FDA says to throw it in the trash—is not working together. Could the Minister elucidate on why the British Government still feel these tests are safe when the FDA says they should be thrown in the trash? Which part of the FDA’s analysis do the Government disagree with?

The key issue for me is the one that the noble Baroness, Lady Thornton, has already raised: this is not linked into the total public health system to deal with the virus. The key issue is not the standard of the tests themselves but that it should be linked into test and trace. To say that we are going to have a high standard without linking it into the test and trace system is like saying you want the best electric car in order to be environmentally friendly, buying it and then, once you get it home, realising that the nearest charging point is 100 miles away. This is not fit for purpose. To be so, tests must be integral and integrated into the test, trace and isolate part of the public health response to coronavirus.

I ask the Minister, as I and others did in Grand Committee: if someone carries out a private test, how does that link into test and trace? There is no mandation anywhere in UK law to say that a private test, once proved positive, has to be fed into the test and trace system. All the evidence suggests that the way to deal with the virus most effectively is to break the chains of transmission within 48 hours. If tracing is not told that you have tested positive, there is no way to have an effective public health response. So, even if you have the best standard of tests, with no tracing or isolation the chain of transmission will continue.

When I and others asked in Grand Committee, the Minister said that this is also a significant public health policy change. I am not aware of any infectious disease anywhere in the UK or in the world where a market approach to the testing of infectious diseases has become the bog-standard approach, but that seems to have been the Government’s policy after September.

The Minister mentioned Germany in Grand Committee, saying that that country had moved to a specifically private-led testing system. There are two differences in the German system. First, it is controlled by state subsidies; to do it, the companies get a state subsidy, which has now been reduced significantly so the level of private testing is levelling off. Secondly, and most importantly, there is a mandatory requirement in German law to report positive cases from those positive tests to the national Covid test and trace system in Germany.

This statutory instrument, while well intentioned, is riddled with weaknesses. It is not linked to the test and trace system and will not help keep the country safe. It will not have the desired effect, and we will end up with a system that basically has a good standard of tests but then does not do the next, vital part, which is to trace people and then support them in isolating.

That is why we on these Benches will support the amendment to the Motion tabled by the noble Baroness, Lady Thornton—unless the Minister can come up with convincing answers this time, not just soothing words.

My Lords, I thank the noble Baroness, Lady Thornton, for her support for the regulations in the round, for her supportive words about the role of the private sector in the round and for raising many important points in her amendment to the Motion, stressing the vital role of NHS testing as we continue to manage the pandemic.

I want to clarify that these regulations are not connected to the future of free NHS testing. This SI, as noble Lords have noted, is solely focused on ensuring the quality of any Covid test in the UK and that they are of the same standards as I would procure for the NHS.

It is self-evident that poor-quality tests, when used privately, could pose a risk to the health of not only the individual but the public. All that is necessary for entry of Covid test products into the UK market is controlled by EU CE marking, which, as noble Lords noted, is currently a self-declaration process for most Covid-19 tests on the UK market. The performance declaration made as part of this EU marking does not need to be independently verified ahead of sale of such tests. There is no legally binding agreed process for establishing performance. That just is not good enough. It became clear as I sought to procure tests at scale for the national effort that many kits that had passed a CE mark were not fit for the real world. I say to the noble Lord, Lord Hunt, that it is not right that the quality of tests correlated to any particular nation; this applied to all nations.

I say to the noble Lord, Lord Alton, that we have audited the supplies of medical devices and there are no current slavery or human rights concerns. We do, however, remain vigilant. I regret that his question on sourcing has not been answered, particularly because there is a very large amount of public material on the procurement framework, the suppliers to it and the arrangements we make to run that framework. I will address that gap with speed, and with regret.

I reassure the noble Lord, Lord Scriven, that there is a very large amount of published material on the internet on the validation of tests, including the protocols and the results from Oxford University and Porton Down, which conducted the validation of the tests. These validation protocols have been assessed by a very large number of experts, and I would be glad to send him links to the protocols and the assessment processes. I reassure him that our tests have been tested against alpha, beta, gamma and delta variants and successfully detect all of them.

The noble Lord, Lord Alton, referenced “kickbacks” to the Communist Party. I very kindly and respectfully ask him to remember that British officials have operated a remarkable procurement programme during the pandemic at the very highest standards of integrity. I gently ask him to provide evidence for such accusations before making them in the House.

To the question of why we buy so many tests from China and not from Britain, the simple answer is that they pass our protocol and meet the requirements of the procurement framework regarding quantity, speed and product design, for example. We buy them to ensure a good deal for taxpayers and effective tests for the public.

I completely agree with the noble Lord, Lord Hunt, that we need a strong UK manufacturing base. I reassure the noble Lords, Lord Alton and Lord Scriven, and others who have raised this point that we have a major programme on this, with subsidies, expertise and support available. I would be glad to arrange a briefing session to run noble Lords through all the measures we have in place to support the UK diagnostics industry. I believe the high-quality regulations we are discussing today provide the certainty business and investors need to invest in the UK diagnostic system. We need this market to provide additional capacity at the time of the pandemic, to ensure that we have outstanding testing capability while also encouraging innovation.

I was keen to take an evidence-based approach to developing this policy, so we ran a very successful consultation that had a broad range of respondents. Some 73% agreed that mandatory validation of tests prior to entry to the market was the best approach; 88% of those agreed that this should be legally backed; 71% agreed that a validation process would not significantly reduce supply; and 79% agreed that mandatory validation processes will increase safety.

In April this year we launched the universal testing offer, so now anyone in England can access free LFD self-tests by ordering online or collecting then at over 9,000 pharmacies across the country. To reassure the noble Baroness and all noble Lords concerned about this, our recently published road map out of lockdown made it clear that we are keeping in place key protections, including free testing for people with symptoms, but we are standing down the workplace testing regime, as the noble Baroness, Lady Thornton, rightly pointed out, from 19 July.

On the rationale for regulation, I welcome the support of the noble Baroness, Lady Thornton, for NHS tests, which have always been of the highest standard. The objective of the legislation is to ensure that the same high standards for tests that we see upheld when the Government buy them are equally reflected in the testing market for all consumers. That market already exists in this country; over 1,000 providers are already going through the UKAS accreditation process. These tests are being used to enable activity across many areas of the economy, including travel, film, TV production and sport. It is critical that we put in place processes to ensure that these tests are high quality and accurate: that is what this law does.

On the integration of private tests and the NHS test and trace system, I reassure the noble Lord, Lord Scriven, and the noble Baroness, Lady Thornton, that significant work has already successfully linked private sector testing results with the NHS Covid app, the JBC and test and trace. When a test is conducted by a testing provider, whether public or private, the result of that test, whatever the outcome, is legally required to be reported to PHE as a notifiable disease by the provider. To the noble Lord, Lord Scriven: this is true for a private test or a public test, and I would be glad to send him a copy of the long-standing regulations that make this law. This must be done within 24 hours for all positive tests. Any self-administered test provided by the Government can be reported via our online portal by members of the public. Any positive test reported to PHE will be passed on to our contact tracing system.

The draft impact assessment has now been published in the interest of transparency, as has an impact statement. It is a living document, and we want to make the best analysis available. We intend to update the impact assessment and address the RPC’s comments ahead of the introduction of the second SI in the autumn. I would like to put on record my thanks to the RPC for working so closely with us and at such pace on this matter.

I want to ensure that all tests are available in the UK, whether they are offered by the NHS, a charity or a private provider, and whether they are supplied by a British diagnostic firm or an overseas firm. I thank the noble Baroness for giving me this opportunity to respond to her important points. I beg to move.

My Lords, I start by thanking the Minister. I feel for the Minister, and I wish him well in his self-isolation, and I congratulate him on his immediate and unfussy decision to obey the ping and the trace system. I hope he is going to have a great summer, because I think he has earned it.

I thank the noble Lords, Lord Hunt, Lord Alton and Lord Scriven, for their support and the questions they have asked. I apologise to the House that we did not put this amendment down in the first place. It should have come straight to the floor of the House rather than going through the Grand Committee first. It was only the gathering concern in Committee that led me and other noble Lords to the conclusion that we needed further discussion about this.

It is not up to the noble Lord, Lord Alton, to prove the veracity of the sources of any goods we purchase through the NHS or anywhere else. If it is being bought by the Government, it is up to the Government to demonstrate that those supply lines are not exploitative and do not use slave labour. That is part of the transparency we are calling for. I do not think the Minister answered very well on that matter.

I am concerned that workplaces, as I suspected, will now have to pay for the testing regime we have. I am somewhat reassured by the noble Lord assuring us that tests have to be fed in through the test and trace system wherever they happen, but I am concerned that, given that workplaces will now have to purchase all those tests, the system will break down quite quickly over the summer. We still have many questions and regrets, so I wish to test the opinion of the House.

Motion agreed.