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

Alex Norris Excerpts

Wednesday 14th July 2021 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to serve under your chairship, Mr Davies, and to be part of the proceedings that make first use of a new power under the Medicines and Medical Devices Act 2021; it feels like a long time since we were sitting in a similar Committee Room debating that Act. I am grateful to the Government for the briefing session for Members of both Houses last week, in which we were able to ask a number of important questions.

High-quality testing is a crucial part of fighting coronavirus. Knowing who has it and who they have been in contact with, and supporting them and their contacts as they isolate themselves, is a core way of preventing transmission. Even as we start to reopen significant aspects of British life, that basic principle will remain with us for some time, so it is right that testing be put on a high-quality, properly regulated footing. While members of the public are not at direct risk from bad tests, the knock-on impact of a false positive or negative is serious, so we need to set up a regime that reduces the risk of that as much as possible. Of the 280 tests available, only 50 would pass the relevant standards. That is sobering, and good reason for us in this place to act. We therefore do not intend to divide the Committee, but I would like details from the Minister.

The explanatory memorandum describes the regulations as “urgent” action. We are some 16 months into this crisis, and the powers have been available under the 2021 Act for some months; is this the fastest the response could have been? When the regulations were considered in the other place earlier this week, there was a suggestion that the reason for the new-found urgency was that the Government wish to transition to a charging model of testing, rather than the current public health model in which tests are made widely available for free. Lord Bethell said that was not the case; I am hoping that the Minister will give the same commitment, and will say that free testing will be available after the regulations are approved next Monday, and while we deal with the current peak of infections.

The Minister talked about a partnership going forward. I understand that the Government cannot be expected to carry the entire burden indefinitely, certainly not for private entities, but what will that partnership look like for the rest of this year? Assuming that we do not lose free tests in the short or medium term, there is an expectation that we will start to see an increase in testing through the private route. I did not hear, in the Minister’s opening speech, assurances on how those tests will be linked to NHS Test and Trace. There is value in testing in and of itself—it lets individuals know whether they need to self-isolate—but the point of having a central system is that we can have surveillance around the virus, and critically we can seek contacts and get them to isolate, too. Will the obligation still be on the individual, and will there still be support from the state?

I asked this at the briefing but did not get a particularly detailed answer, so I will try again. On the fees regime, we support, of course, the discount for small and medium-sized enterprises, which make up the bulk of the market, as the Minister said. In general, though, that £14,000 figure seemed quite high, not to mention suspiciously rounded, for a full cost recovery model. Will she share the breakdown of the costs? If she does not have that information with her, perhaps she might put it in the Library, because there is interest in it.

The instrument allows the Secretary of State to exempt tests on a case-by-case basis to avoid supply issues for the NHS. However, tests procured by the Department of Health and Social Care or the NHS are exempt already, so why is that necessary? The main weakness of the 2021 Act was that it allowed too much regulation to be implemented or set aside at the stroke of a pen by a Minister acting as a Caesar, rather than as someone who is accountable to Parliament. There does not seem a lot of point in doing what we do, either downstairs or up here, if a Minister can later decide that they are not interested in a certain provision of a regulation or Act. That should be avoided as much as possible, and I cannot see its value in this case. I may be missing the point, but I hope the Minister will address that, or at least say what safeguards will be put in place, and what reporting there will be of the provision’s use.

In a growing market such as this, there will still be some who choose to break the rules, thinking it a route to quick profit. Presumably the enforcement will be for the Medicines and Healthcare products Regulatory Agency. Is it suitably resourced to tackle this in the short term, as it beds in? Will it have a specific team on it? Similarly, what will the fines regime look like, and will it compound for repeat offenders?

To finish where the Minister finished, the shadow Health Secretary, my right hon. Friend the Member for Leicester South (Jonathan Ashworth), is fond—I wish he was not so fond—of saying that we are in an era of pandemics. I am not attracted to that characterisation, but as the Minister put it, disease management is something that, globally, we clearly have to get much better at. This may not be the last time that we deal with something like this. The points that she made on the management of the Ebola virus were very interesting. On future-proofing, how portable is this model for testing in future pandemics? Or will it hold merely for covid-19? Rather than waiting 16 months, we would be able to implement it much more quickly.

As I said, I do not intend to divide the Committee. I know that I have fired off a number of questions. I hope that, if the Minister does not have all the information today, she might be able to follow up in writing.