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

Volume 834: debated on Monday 27 November 2023

Motion to Approve

Moved by

That the draft Regulations laid before the House on 19 September be approved.

Relevant document: 1st Report from Secondary Legislation Scrutiny Committee

My Lords, I draw the House’s attention to my declaration of interest in the company that I founded, which was accredited under these rules. The fact that it is accredited means I have some experience, which always helps in an area. It is not affected by these regulations, but I was keen to state that for the record.

The 2023 regulations update the legislation introduced in 2020 to impose requirements on private providers of Covid-19 diagnostic testing. Once they are implemented, private providers will need to be accredited by a signatory of the International Laboratory Accreditation Cooperation mutual recognition arrangement before they can supply testing. These measures replace the current three-stage UK Accreditation Service process with a simplified and streamlined one. They also remove requirements that are no longer necessary due to legislative developments that have taken place since 2020. The changes will empower consumers to choose a private testing service with confidence, continuing to improve safety and quality. 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 be able to rapidly enter the private testing market. This struck the appropriate balance at the time between protecting public health and growing the market quickly.

I am pleased that the worst of the pandemic is behind us, so the urgent need to grow the Covid-19 testing market quickly no longer applies. The department has therefore reviewed the 2020 regulations and proposes that all private providers must be fully accredited before providing testing services. This amendment will bring in requirements and standards that help to strengthen consistency, safety and high-quality Covid testing services.

I am pleased to be debating the statutory instrument that is necessary to implement our proposed updates to the existing legislation. The 2020 regulations introduced a three-stage accreditation process for organisations providing Covid testing commercially. The three-stage accreditation process requires providers to satisfy the UK Accreditation Service that they meet the relevant ISO standards within a set timeframe. Stage 1 requires the private provider to make an application to UKAS for accreditation and make a declaration to DHSC that they meet and will continue to meet certain minimum standards. Stage 2 requires the applicant to demonstrate, within four weeks of applying for accreditation, that they meet requirements published by UKAS. From January until June 2021, stage 3 required providers to complete their application within four months.

We wanted to ensure that a greater number of high-quality applicants were given sufficient opportunity to complete the process and reduce resourcing constraints on UKAS while maintaining quality control. In June 2021, we passed legislation to update stage 3. Applicants were now required to achieve a “positive recommendation” from UKAS within four months of completing stage 2. Provided they received this, they then had a further two months to achieve accreditation. Providers who fail to meet any of these deadlines, or fail to satisfy UKAS that they meet the relevant standards within this timetable, have to stop supplying testing. The purpose of this approach was to ensure that enough providers were able to enter the market soon enough to meet the public demand for testing. It ensured that we were not as a country left with insufficient testing capacity while still putting providers through an appropriate process.

Now I move to the substance of the regulations. The 2023 regulations implement several policies coming into force from 1 January 2024. First, private providers—diagnostic laboratories, sample collection and point-of-care testing—must be accredited against the appropriate ISO standard by a signatory to the International Laboratory Accreditation Cooperation mutual recognition arrangement before they can start supplying their service. This replaces the three-stage accreditation process. Since setting up this process, the Medical Devices Regulations 2002 were updated to prescribe a specific process for the validation of Covid-19 test devices. We therefore no longer need test validation measures in these regulations as well, so we are removing those. Secondly, the amendments reflect the publication of the updated ISO Standards 15189:2022. The amendments are forward-looking and do not affect private providers who applied under the previous ISO standards—ISO/IEC 17025:2017—before this instrument came into force. Lastly, this instrument removes the requirements to make a declaration to DHSC at the start of the application process and shifts the legal responsibilities for the clinical service to the private providers providing the clinical service, rather than the customer-facing part of the testing service.

The amendments will hold providers to high standards, by requiring them to be accredited before they can join the market. This will give confidence to individuals choosing Covid-19 testing services. The amendments also remove the additional requirements and administrative steps that were necessary in the early stages of the pandemic. Those who have already achieved accreditation will be unaffected by the change; that is, they will not need to reapply for accreditation under the new regulations. All private providers will be required, as normal, to transition to the new ISO standard by 6 December 2025 at the latest.

The amendments allow private providers who are accredited by a signatory of the International Laboratory Accreditation Cooperation mutual recognition arrangement to enter the market. The UK Accreditation Service is one of 90 accreditation bodies that have signed the arrangement. It enhances the acceptance of products and services across national borders. By accepting accreditation from these signatories, we help to remove barriers to trade such as the retesting or inspection of products.

Private providers must be accredited to the relevant ISO standards for clinical testing services. These standards were reviewed and updated in 2022 and transition proceedings have begun: the old standards will be revoked in 2025. The existing 2020 regulations do not reflect the updated ISO standard. So, if we did not make these amendments, providers who transition to the new ISO standards—as they are required to do—would not under our own rules be able to provide testing services. This is a clear lacuna that we need to address.

I am happy to be bringing forward this legislation today. These regulations will reduce bureaucracy whilst still delivering rigorous accreditation requirements, important for public health. I commend these regulations to the House.

My Lords, it is good to be able to debate a piece of legislation that is quite technical but still quite important. The regulations themselves are entirely sensible as tidying-up legislation after the coronavirus pandemic, but they trigger a few points that are worth putting on the record and seeking a response from the Minister on.

The first is just to note that it is good that we are following the international standards on this. I am sure all noble Lords experienced that period during the pandemic when there was confusion around which countries accepted whose tests and it became blindingly obvious that we needed international recognition. It is pleasing that we are following a standard that, as the Minister said, 90 bodies are now signed up to. It is good to have the confidence that when we pay for tests here in the United Kingdom, there is a good chance that they will have that international recognition. Does the Minister have a sense of whether other countries are following a similar path, where they implemented a special regime during the pandemic that they are now transitioning into a normal regime, just as we are doing today? Is the United Kingdom in step with other countries or are we ahead of or behind them? It would be interesting to know that; I assume the department has done some work around it.

The second is on whether there has been any post hoc assessment of the special regime that we had in place for getting testing up and running—as the Minister said, we were trying to do that urgently. Were there any material differences in outcomes between that special regime and the business-as-usual regime? In other words, did we introduce any additional risk by having this faster-to-market process, and is any research going into understanding whether there was a material difference in the special regime?

The third is on whether there is now a plan in place for emergency testing regimes in future. Sadly, we have to anticipate that there will be other pandemics. I note that in the news today there is discussion of influenza transmitting; I think it is a swine-based influenza that seems to have been transmitted to humans. We are monitoring novel pathogens all the time and, unfortunately, in future they may replicate to some extent what occurred during the pandemic. It would be nice to know that there is a plan in place for what we might call a routine emergency. If we can predict the emergency, surely we can predict whether we will need another special authorisation testing regime. Perhaps we can get there quicker next time rather than having to make it up on the fly, as we had to this time because it was our first experience of it.

The fourth is on whether there are any implications in these regulations for other forms of private testing. For example, I know that the private sector may want to test employees for influenza and that there are private testing regimes available for other diseases, such as ordinary influenza. Does the regime that we are now implementing for Covid testing have any broader implications, or is it limited specifically to Covid testing and will other forms of disease testing be entirely unaffected by it?

The final point is to understand whether there has been any reaction from testing providers. How do they feel about this transition, in both senses—to the special regime and now out of it into a business-as-usual regime? It is interesting that we are told there is no need for an impact assessment of the regulations because it is too small now. The impact assessment process is useful and, if we do not do that process going into the special regime, because it is too urgent and there is no time to do it, and then do not do one coming out, because by that stage it is too small a market and we no longer think it valid, that raises an important question for our proceedings. At what point do we look at the financial impact of bringing in a regime like this and then moving out of it if, as I say, we are not testing on the way in or the way out?

We have no opposition to the regulations themselves. These questions were simply an opportunity to flesh out the learnings from what we all went through in the pandemic.

My Lords, I thank the Minister for introducing these regulations, to which we too are pleased to give our support. We have clearly moved on from where we were in 2020, when the original Covid regulations for testing service providers were agreed and “lateral flow device” was not a household term. Looking back to 2020, these Benches supported the regulations then because we recognised the urgent need to enable new service providers to meet the demand for testing services. We also noted that that had to be balanced with the importance of public health protections and regulations to build safeguards into the system and, so importantly, to give people the confidence that services could be trusted to keep them safe.

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 these services are no longer subject to the additional requirements introduced early in the pandemic and, as such, reflect an update to meet us where we are now. They also reflect the update to the international standards since last year.

It is important to acknowledge what the regulations will not change. As the Minister said, providers will still be required to seek accreditation against the appropriate ISO standard. Test devices will still need to meet the requirements set out in the Medical Devices Regulations 2002, just as they did before the pandemic. In my view, this strikes the right balance. As the UK Health Security Agency has noted, accreditation was not mandatory prior to the pandemic but NHS England and Public Health England endorsed all medical laboratories being accredited with the United Kingdom Accreditation Service. 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?

As it is so important that we learn lessons from the past and apply them to the future, I have a few questions on this generality to the Minister. What confidence does he have that new providers will be able to meet the various deadlines to meet the new ISO requirements? How will the regulations we are discussing be enforced? Does the United Kingdom Accreditation Service have the resources it needs for enforcement? How many fines have been issued to non-compliant providers since the 2020 regulations came into force?

I am sure that the Minister will agree that 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 department made of how the market is changing and how such diagnostic capabilities could be deployed to meet other ends?

In concluding, I take the opportunity to ask the Minister about one of the biggest scandals among private providers during the pandemic: that relating to the company Immensa. 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, were being wound down. Immensa was awarded more than £100 million in a contract 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. It was also found that PCR 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 extra deaths.

I have specific questions on this issue and I would be grateful if the Minister could respond to me, if not now then in writing. 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, yet 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 UKHSA found that, despite requirements for accreditation being written into the contract, the department and NHS Test and Trace decided that they would not apply. As such, Immensa was not accredited at the time of the false negatives scandal, even though the department claimed otherwise. Is the Minister able to confirm what actually happened in this case?

The findings of the UKHSA report risk undermining the rest of the system, if providers could not be encouraged to circumvent the correct process and there were no consequences as a result. Why were the department 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. Perhaps the Minister can confirm whether this was the case and, if so, why? Given the tens of millions of pounds of public money involved in the scandal and the dire consequences of the mistakes, can the Minister advise your Lordships’ House what efforts the Government have made to get the money back?

In conclusion, these Benches support the statutory instrument. We very much agree that now is absolutely the appropriate time to review the exceptional measures that were taken early in the pandemic while ensuring that appropriate regulation and confidence remains in place.

I thank noble Lords for their responses and generally for the support they offer for what we are trying to do here. As I say, for a lot of my answers I will draw from personal experience. The whole of that time was extraordinary, as we know. To my knowledge, it was the first time where you had a situation in which masses of people could be tested for something. However, it needed laboratory-based testing, and suddenly the amount of volume needed for the general public was completely out of anyone’s imagination as regards the volume of the market. I remember trying to understand the rules at the time, as somebody who might set up such a company to do this, and I quickly found out that there were no rules, in that nobody had ever quite envisaged such a situation and the only rule that existed was around getting an ISO process, which typically took 12 to 18 months.

What the Government did there—again, I am speaking from the other side of the fence—was to create a good process of trying to funnel people, starting off with quite easy ways to get you through the funnel because they wanted to expand it as much as possible, but then effectively making it progressively harder while still trying to keep the good suppliers in the mix. By and large they did a decent job on that. I saw some providers completely gaming the system, in that they kept ticking the boxes as long as they were allowed to tick them and then as soon as it came to a hard task, for want of a better word, they folded up shop. There was definitely some of that, and the funnel sorted out some of the wheat from the chaff along the way, but at the same time I will not pretend it was a perfect process.

I say all this from sitting on the other side of the fence and having to jump through necessary hoops, but I actually think it was a decent process at the end of the day. As ever, I will come back in writing on all this, but my understanding was that it was a fairly similar process to that followed by other countries, and they are now going through a fairly similar process to regularise this.

As I said, I absolutely looked at the difference in outcomes versus existing regimes, and I am under no doubt that, if we kept the rules of the existing regimes, the supply would not have expanded in the way required at the time. On what the Government were trying to achieve, the evidence shows that they achieved a decent outcome, where, by and large, the quality outcomes were pretty good, although not perfect—the noble Baroness brought up a good example of where it definitely was not perfect. By and large, they did a decent job on that.

That brings me to future emergency testing. Here we are no doubt reverting to the old rules, which are probably sensible where we are. Of course, the capacity in the marketplace is much greater now—I do not have the exact numbers, but I can send them—because a lot of these companies exist and there are a lot of PCR machines and other types of equipment. If there were similar circumstances again, those resources are there to be stood up pretty quickly. If it were outside those parameters—for want of a better word—we would probably need to bring in a similar type of regime again, albeit learning from the experiences, having done it once. They probably got a seven out of 10 the first time around and I hope could get an eight or nine out of 10 this time around.

I come to the regulations for the other forms of private testing—this covers a multitude of things. One of the big values from the pandemic is lateral flow, the accuracy of which has massively increased. If it were to happen again, most of the testing would be done through lateral flow. That is not affected by the instrument because it is not laboratory based. For most forms of private testing done by companies, it is the lateral flow-type situation, which will not be regulated by this. However, where it is lab based, my understanding is that there will be a similar set of circumstances. Again, I will follow up in writing on all this. Generally, the reaction from the testing providers is that this is quite sensible—it is trying to regularise that situation.

In response to the question of the noble Baroness, Lady Merron, I mentioned that the ISO process is quite lengthy—typically 12 to 18 months. However, typically, labs that are already established in this field add on more ISOs and qualifications to expand what they currently have, so, on that 12 to 18 months, they are not starting from zero: they have already gone a long way to begin with. The 12 to 18 months is for new providers starting from scratch. As per the answer to the previous question, if there were another pandemic in the future, we would probably have to introduce something similar again if we needed to expand the supply in new ways. Because of that and the confidence of the new providers, I think that is generally seen as sensible.

I do not have answers on the fines issued under this, so I will need to come back on that. On the numbers at the peak and now, I can say from personal knowledge that the market generally has shrunk back a lot to the bigger, established players that were there in the first place.

On Immensa, I remember this from being on the other side of the fence at the time and being angry, to say the least, on a personal basis, that there was such a set-up. It did the whole industry damage and, much more importantly, it put lots of people at personal risk. That was a very sorry episode. To do it justice, I probably need to give a detailed written follow-up, which I shall do for all these questions.

I think, and I hope, that I have covered as much as possible, and I shall follow up more on this in writing. I welcome the support of noble Lords generally for these regulations and commend them to the House.

Motion agreed.