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

Baroness Thornton Excerpts

Tuesday 20th July 2021 Lords Chamber

Moved by

[Baroness Thornton]

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.”

[Baroness Thornton (Lab)]

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.

[Lord Hunt of Kings Heath (Lab)]

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?

--- Later in debate ---

[Lord Bethell (Con) [V]]

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.

[Baroness Thornton (Lab)]

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.