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

Lord Hunt of Kings Heath Excerpts

Tuesday 20th July 2021 Lords Chamber

[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?