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

Baroness Merron Excerpts

Monday 27th November 2023 Lords Chamber

[Baroness Merron (Lab)]

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.

[Lord Markham (Con)]

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.