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

Lord Alton of Liverpool Excerpts

Tuesday 20th July 2021 Lords Chamber

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?

[Lord Alton of Liverpool (CB)]

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.

[Lord Scriven (LD)]

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.