Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 — House of Lords, 2021-07-20
Topic: Health
Paul Scriven (Liberal Democrats, Centre to centre-left): 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.