Draft Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023

Preet Kaur Gill Excerpts

Wednesday 22nd November 2023 General Committees

[Preet Kaur Gill (Birmingham, Edgbaston) (Lab/Co-op)]

It is a pleasure to serve under your chairship, Mr Paisley. The Opposition support the regulations because they represent the right balance between the promotion of innovation and public health.

We are clearly not where we were in 2020, when the original covid regulations for testing-service providers were agreed and “lateral flow devices” was not a household term. We no longer live with the constant fear that the NHS could be imminently overwhelmed—at least not by covid-19 patients. That has been a testament to the incredible work of our NHS, civil servants, the academic community and the millions of ordinary Britons who pulled together at a time of national crisis to overcome the pandemic.

That work is why Labour supported the 2020 regulations. We recognised the urgent need to enable new service providers to meet the demand for testing services—which were critical to opening up our economy and taking pressure off the NHS—but also to balance that with the critical importance of public health protections and regulation to build safeguards into the system and give people confidence that services could be trusted to keep them safe.

Of course, covid remains notifiable to the UK Health Security Agency for all laboratories in England that perform a primary diagnostic role, which is critical to the monitoring of national trends, so we support the need for sensible regulation of such an important sector. We promised to work with the Government in the national interest; we did and we still do.

As the Minister outlined, the regulations apply to clinical covid-19 testing services, such as diagnostic laboratories or those that carry out point-of-care testing. The regulations will mean that those services are no longer subject to the additional requirements introduced early in the pandemic, such as the three-stage UKAS accreditation process and the requirements to submit tests for additional validation and to ensure that the testing process is overseen by a clinical director. They also reflect the update to the international standard since last year.

It is important to stress what the regulations will not change. Providers will still be required to seek accreditation against the appropriate ISO standard, and test devices will still need to meet the requirements set out in the Medical Devices Regulations 2002, as they did before the pandemic. This seems to strike the right balance. As the UKHSA has noted, accreditation was not mandatory prior to the pandemic, but NHS England and Public Health England endorsed all medical laboratories being accredited with UKAS. The process for laboratories to achieve accredited status took anywhere between six and 12 months; given the changes we are discussing, how long does the Minister expect the accreditation process to take now?

It is important that we learn lessons from how the regime worked during the pandemic and apply them going forward, so I hope the Minister will not mind if I ask a number of questions. What confidence does she have that new providers will be able to meet the various deadlines to meet the new ISO requirements? How will the regulations be enforced? Has she ensured that UKAS has the resources it needs for enforcement? How many fines have been issued to non-compliant providers since the 2020 regulations came into force? If—God forbid—there was another pandemic tomorrow and we needed similar regulations again, would she do anything differently?

It pays to think about the state of the market now. How many UKHSA-accredited providers were there at the pandemic’s peak, and how many are there now? As some companies wind down their covid-19 testing capacities because of reduced demand, what assessment has the Minister made of how the market is changing and how such diagnostic capabilities could be deployed to meet other ends?

Finally, I want to take the opportunity to ask the Minister about one of the biggest scandals among private providers during the pandemic: Immensa laboratories. I remember writing to the Government about this case. Local public health experts were baffled as to why an NHS Test and Trace contract had been given to the company while high-quality diagnostic services, such as those at the University of Birmingham in my constituency, were being wound down.

Immensa was awarded more than £100 million to carry out covid testing in September 2021, without going through the normal tendering process. It was subsequently found to have been one of 50 firms that had been put into the priority lane for test and trace contracts worth billions. As my hon. Friend the Member for Oldham East and Saddleworth said, it was found that PCR—polymerase chain reaction—test results from Immensa’s Wolverhampton lab had misreported around 40,000 positive results as negative between September and October 2021, leading to significant additional infections at a critical time and an estimated 20 deaths.

I have specific questions on this issue. Neither Immensa Health Clinic Ltd, nor its related company Dante Labs Ltd, was accredited by UKAS at the time of the scandal, despite the regulations that we are amending today. Immensa was a new entrant to the market and was supposed to go through the three-stage process, and it was awarded vast sums of public money to rapidly expand the capacity of NHS Test and Trace in the autumn of 2021. One would expect high standards from a private provider in exchange, but that did not appear to be the case.

An investigation by the UK Health Security Agency found that despite requirements for accreditation being written into Immensa’s contract, the Department of Health and Social Care and NHSTT decided that they would not apply. As such, Immensa was not accredited at the time of the false-negatives scandal, even though the Department’s spokespeople claimed otherwise. Will the Minister clear up what actually happened in this case?

The findings of the UKHSA report risk undermining the rest of the system, if providers can be encouraged to circumvent the correct process and there are no consequences as a result. Why were the Department of Health and Social Care and NHS Test and Trace so determined that special measures should be put in place for this provider? I am not aware of any consequences for any officials or Ministers responsible for the shocking findings of the UKHSA investigation; why not? Given the tens of millions of pounds of public money involved in the scandal and the dire consequences of the mistakes, what efforts have the Government made to get that money back?

To reiterate, the Opposition support the statutory instrument. We agree that now is an apt time to review the exceptional measures that were taken early in the pandemic while ensuring that appropriate regulation remains in place.