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

Baroness Thornton Excerpts

Monday 12th July 2021 Grand Committee

[Baroness Thornton (Lab)]

My Lords, the importance of this SI is underlined by the decision of the Secondary Legislation Scrutiny Committee to draw the regulations to

“the special attention of the House on the grounds that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.”

The noble Lord, Lord Scriven is quite right: this is not emergency legislation. Here we are, more than a year in. It is not an emergency. However, this is a very important statutory instrument. My noble friend Lord Rooker and the noble Lord, Lord Lansley, have outlined many of the questions that need to be addressed, but I need to put the Minister on notice that, depending on his answer to this debate, I may oppose it here in the Grand Committee and take it to the Floor of the House.

I am very concerned listening to this debate. I was concerned when I made my own notes, and I am even more concerned now listening to other noble Lords. This is not just about the quality of testing; it is about the market of testing, and that is quite different. That is why the Secondary Legislation Scrutiny Committee was concerned about a major change in public policy. Putting a major change in public policy through in Grand Committee under these circumstances is probably not a good idea and does not make for good legislation.

We absolutely support a quality approval process for all Covid-19 tests in the UK. It is important that the new process is rigorous to ensure that all tests, including those for sale, meet the relevant quality standards, especially if such tests are to play a greater role in the long-term management of Covid-19. In the meantime, it is essential that free NHS tests continue to be available. This is all the more important given the rising case numbers and the Government’s insistence on going ahead with the removal of all restrictions, including the legal requirement to wear face coverings on public transport, in a week’s time.

Given the importance of reliable high-quality testing devices for the effective management of Covid-19 in the long term, can the Minister explain why the new validation process was not introduced earlier? Given that the DHSC says that as part of managing Covid in the long term the Government will want to support

“a thriving private sector market for COVID-19 detection tests to supplement and support testing led by NHS Test and Trace”

and to

“encourage the private sector to bring a number of testing products and services to market to meet the differing needs of businesses and individuals”

and provide consumer choice, how will we ensure that all the tests available will meet the minimum performance standards? According to the department, the new quality requirements introduced by this instrument

“will make the UK private testing market more competitive, as manufacturers will need to improve the accuracy and speed of their tests in order to outcompete competitors”.

Can the Minister confirm the timeframe for shifting to a private testing model? How much will these tests cost and who will bear the brunt, employers or employees? Will there be waivers or business support for vulnerable workplaces, including hospitals, care homes and schools, as well as other key workers where frequent testing is key to protecting the vulnerable and often to things such as keeping a school open? Does he agree that it is essential that free NHS tests continue to be available, given the rise in case numbers and the Government’s insistence on going ahead with opening, as I have already said?

I would like to have some more information about the August cut-off point. During the procurement of lateral flow device tests for the NHS, only 25% passed through all stages of validation including the assessment for performance and quality standards under the current regime. The 75% of the LFD tests assessed as not meeting performance or quality standards of the NHS still qualify as fit for market. The DHSC says that rapid intervention is therefore required to address this. Does rapid mean now or a year ago?

Department of Health and Social Care data showed that six out of 10 positive rapid test results at schools between 4 March and 17 March turned out to be wrong. It is therefore legitimate to ask whether the real reason that we are backing away from them is because they do not work for self-testing and do not represent value for money. What is going to happen next? The Minister needs to set out the timescale. Can he confirm that if the third-party approach is to be considered, these contracts will go out for public tender?

Does the Minister share my concern that the department’s explanation appears to suggest that less accurate tests can be of diagnostic value for the NHS if such tests are used by clinicians who are able to consider other factors and information and therefore put any tests into a wider clinical context? Finally, what extra resources will be available to local authority trading standards teams for testing enforcement activities?