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

Lord Scriven Excerpts

Monday 12th July 2021 Grand Committee

[Lord Scriven (LD)]

My Lords, of course these Benches welcome the general thrust of the regulations—that tests should be safe and that there should be a standard across the UK. However, we also raise the same issue as a number of noble Lords, including the noble Lord, Lord Moynihan, about their timing, and ask why this is emergency legislation. I am afraid it is becoming a bit of a trend that the Government bring things through in emergency legislation. If the instrument had come through a different route in which we had a lot of time, we could have asked many of the questions that we are now asking, and improved and amended the legislation to deal with some of the issues. This is so important, because this is about testing and trying to give the country a sense of what the new normal will be.

The underlying basis of this is a significant change of public health policy. I am not aware of any other infectious disease where public health policy on testing is left purely to the market—unless the Minister can advise otherwise. There is a real issue of this being about not just market failure but the role that public health, public health professions and the public sector will play to ensure that this works.

I say that because, without being linked to the test and trace system, there is a sense that testing in itself will become not as effective as it could be. This SI assumes that public policy will be for most testing to be done outside the NHS, and possibly for a charge. So once these tests are approved and there is a standard, how do mandatory tests then get into the tracing part of test and trace? There is no legislation at present to suggest that has to happen. Employers, or particularly an individual at home, could take a test and it turn out to be positive. Coming back to what has been said many times before in the House and in Grand Committee, if people feel that they cannot afford to self-isolate, they are not going to give details about them being positive.

The question is: if this becomes predominantly a market-driven approach, done by employers and businesses bringing in customers, as the Explanatory Memorandum suggests, or by individuals at home, how does that then trigger tracing? How will it trigger a person having to inform somebody, either locally or nationally, through test and trace, that they are positive? Significantly, how will tracing then kick in to help ensure that the chains of transmission are dealt with as speedily as possible, particularly since evidence suggests that 48 hours is the maximum time before the chain continues to spread?

Regulation 39A says that the Secretary of State can make an exemption for tests coming on to the market which are not tested. In what circumstances does the Minister feel that the Secretary of State would be able to use the power under Regulation 39A? How will it be reported to Parliament or to the public, so that they know whether the test they are getting—or potentially buying—has not been through the statutory testing regime?

I want to further explore something mentioned by the noble Lords, Lord Lansley and Lord Rooker. It is to do with the Innova test and the recommendation in the email from the Food and Drug Administration, which said that this test should be thrown “in the trash”—that was the exact quote. Since it was a class I recall, I need to know what extra testing or analysis has been done by the UK Government based on what they have seen from the FDA and that recall. When was that done and what is the outcome of that testing or analysis, based on the extra evidence that has come from the FDA?

Finally, I would like to ask whether free testing will still be available on the NHS. If it is to be available, a number of questions arise. If I could have free testing on the NHS and it is not means-tested, why would I buy a test, unless certain categories of organisations will not be allowed to use the NHS test? At the moment, people going abroad are not allowed to use the free NHS test. Is it anticipated to be the same for organisations such as businesses—for their staff and for customers coming in, et cetera? What thought has been put into that?

These issues, and the others which noble Lords have raised, are important because this is a matter of public health and of how we contain the virus in the most effective way possible, while keeping people safe. I come back to my opening remark: this is not emergency legislation. It should have been laid normally before Parliament, so that we could have dealt with it and tabled amendments. I would have hoped to make this better, to keep people safe and to deal with proper testing across the UK.