Draft Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023
(11 months, 2 weeks ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)
I beg to move,
That the Committee has considered the draft Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023.
It is a pleasure to serve under your chairmanship, Mr Paisley. I will begin by setting out the policy context for the regulations, and then explain the effects of the proposed changes. We all remember that during the covid-19 pandemic the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 focused on enabling providers who met appropriate quality standards to rapidly enter the private covid-19 testing market. At the time, the right balance was struck between protecting public health and growing the market quickly, both of which were necessary public health outcomes. Now that the threat of covid-19 is reduced and there is no longer an urgent need to grow the testing market quickly, the Department has reviewed the 2020 regulations and proposes that all private providers must be now be fully accredited before they provide testing services.
The 2020 regulations introduced a three-stage accredit- ation process for organisations providing covid-19 testing commercially, to speed up entry to the market. Stage 1 required a private provider to make an application to the United Kingdom Accreditation Service for accreditation, and to make a declaration to the Department that it met and would continue to meet certain minimum standards. Stage 2 required an applicant to demonstrate within four weeks of applying for accreditation that it met the requirements published by UKAS. Between January and June 2021, stage 3 required providers to complete their application within four months.
In June 2021, we passed legislation to update stage 3, thereby requiring applicants to achieve a positive recommendation from UKAS within four months of completing stage 2. As long as a provider received that recommendation, it then had a further two months to achieve accreditation. Providers that failed to meet those deadlines, or failed to satisfy UKAS that they met the relevant standards, had to stop supplying tests. At the time, our approach ensured that enough providers were able to enter the market to meet the public’s demand for covid-19 testing, while still putting providers through an appropriate approvals process.
However, we are now more than three years on from the start of the pandemic, the living with covid strategy has been in place for over a year and the World Health Organisation has declared that covid-19 is no longer a public health emergency of international concern. It is, therefore, the right opportunity to review and update covid-19 legislation on private providers to bring in requirements and standards to strengthen consistency, safety and high-quality covid-19 testing services.
The proposed changes will empower consumers to choose a private testing service with confidence, while continuing to improve safety and quality.
Debbie Abrahams (Oldham East and Saddleworth) (Lab)
I notice that there is no impact assessment associated with the regulations—why is that? Will the changes to the regulations take into account the investigation into Immensa and the errors that resulted in 39,000 covid tests being inaccurately assessed as negative? Will the Minister reassure us that that will be the case, and explain why there was no impact assessment?
Maria Caulfield
Certainly. I will come in a moment to the standards we are changing to meet those concerns.
First, under the new regulations, from 1 January 2024, in order to enter the private covid testing market private providers will have to achieve accreditation against the appropriate ISO standard by a signatory of the international laboratory accreditation co-operation mutual recognition agreement. That should give Members confidence that providers will now have to meet an internationally recognised standard. There will be consistent testing standards across the board that meet the ISO standard and are accredited by a signatory of that mutual recognition agreement. The new requirements will replace the three-stage accreditation process required under the existing regulations, which I just outlined, to make sure that providers meet a certain standard.
Secondly, we are removing the requirement for providers to get sign-off from the Department at the start of the application process, because they will have to be accredited before they can enter the market; thirdly, we are shifting the legal responsibility for clinical services to the clinical organisation, rather than it resting with customer-facing organisations; and finally, we are removing the duplicative provision for the validation of testing and ensuring that the regulations reflect the publication of the updated ISO standard, which is 15189:2022.
The changes in the regulations are forward-looking and do not affect private providers that have applied for accreditation before the instrument comes into force. Those providers will still need to complete the application process but can do so using the current staged accreditation system.
On the point made by the hon. Member for Oldham East and Saddleworth, we are moving to a system in which accreditation will have to be achieved against the new ISO standard, and that will apply across the board and be comparable to other countries. We will move away from the three-stage process that we used during the emergency phase of the pandemic, when we had to balance risks and benefits. The risk at that time related to the need to get as much testing out to the public as possible, but that has now reduced, so it is important to set high standards so that people have confidence in the tests they get done.
The regulations will reduce the bureaucracy involved in applying for accreditation while still delivering the rigorous accreditation requirements that are important for public health. I therefore commend the regulations to the Committee.
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.
Maria Caulfield
Let me respond to the questions from the shadow Minister. Currently, we have enough testing capability. Testing providers that are already accredited by the current system will not have to reapply, and those currently undergoing accreditation will be able to continue as planned. The new regulations are for providers that want to enter the market.
More than 100 providers currently hold accreditation, and 18 of them were reporting results to UKHSA as of September. A significant number of providers is currently accredited, so we do not anticipate a huge number coming through the new system, but we will keep an eye on that. Since January we have had very few applications, if any, which shows that the current capacity reflects the demand.
If covid numbers took off or there was a variant of concern, the balance of risk and benefit that I talked about earlier would have to be re-looked at and we would look at the accreditation process in that light. Assuming that the living with covid policy continues as it is, we are confident that the regulations will be appropriate to meet the demand of those wanting to join the private market testing sector. We will keep that under constant review, along with the resources needed to manage the accreditation process.
The shadow Minister touched on the specific issue of the testing at Immensa laboratories. As she said, the UKHSA, the arm’s length organisation responsible for that, looked at the issue and published a public statement in November last year on the serious incident investigation. It found that
“no singular action or process implemented by NHS Test and Trace could have prevented the errors within the Immensa laboratory arising”.
However, although Immensa was going through the three-stage accreditation process, when problems were identified and it failed to achieve a positive recommendation at stage 3, it was not allowed to continue, and neither of the relevant organisations has rejoined the private testing market. So it was identified at the time and the UKHSA, the organisation that oversees testing, looked into it.
Lessons will be learned from the covid experience, which is why an independent inquiry is ongoing. I reassure the shadow Minister that we will do everything we can to learn lessons from that. This is exactly why we have the regulations in front of us: at that time there was pressure to get as much testing out to the public as possible, and the three-stage accreditation process was introduced to do that. That is not the case now, so we are able to take a much more robust approach to assessing organisations that want to take on testing. I hope that gives the shadow Minister some reassurance and that I have demonstrated why the regulations need to come into force now. I hope I have answered the questions. I commend the regulations to the Committee.
Question put and agreed to.