Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 — House of Lords, 2021-07-20
Topic: Health
James Bethell (Conservative, Centre-right): 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.