Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020.

My Lords, these regulations will provide an agile and robust regulatory environment for Covid-19 test providers. This is essential to ensuring that everyone has access to simple, effective and high-quality testing services that they can count on.

The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020 will remove all CQC regulatory requirements for Covid-19 test services. Existing exemptions leave inconsistencies, resulting in some Covid-19 testing providers being within the scope of CQC regulation while other providers are exempt. We want to tidy this up. We will simplify the regulatory system for Covid-19 test providers, making it easier to understand for both suppliers and consumers.

The second SI is the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020, which will impose requirements on private test providers to become accredited by the United Kingdom Accreditation Service and to attain specific stages of a process towards this accreditation within a given timeframe, starting on 1 January 2021.

I will say a word on context. Last week, the Medicines and Healthcare products Regulatory Agency recommended authorising Pfizer/BioNTech’s Covid-19 vaccine. While we wait for the vaccine deployment, testing and contact tracing remains one of the most effective ways of controlling the virus. During this important period, the more rapidly we can identify people at risk of infection, the quicker we can get life back to normal. In the last nine months we have built the largest diagnostic network in British history, which is helping us to tackle the spread of the disease and create the long-term capability to ensure that we are prepared to tackle future pandemics. However, we will only defeat the virus if the public and private sectors work together. The private sector has a critical role to play and has shown this time and again throughout this pandemic. I thank those in the diagnostics, logistics, data and associated industries for their contribution to our pandemic response.

In addition, it is not right to look to the NHS to provide every test for every circumstance. Private sector testing can support NHS Test and Trace by offering tests to those who have a reasonable need for testing but are outside the conventional clinical or epidemiological use cases. It can also help to drive innovation. The Government are therefore supporting the development of a private testing market. We want to ensure that everyone has access to simple, effective, high-quality and affordable testing services that they can count on, whether from the Government or a private provider.

As the demand for testing continues to grow and the number of providers increases, we need to reassure the public that quality control is as important as ever. That is why we want to support private providers to ensure that they can enter the market in a timely manner and meet the demand now without compromising the quality of their testing service.

My Lords, I have every sympathy with the Minister being in isolation and thank him for introducing these SIs. Clearly, Covid-19 testing is a critical part of the response to the pandemic, so these regulations are important in ensuring that there is a robust process in place to ensure transparency, effective monitoring and appropriate accountability.

In proposing the new regulatory regime, the Government have argued that it is necessary to remove barriers to entry into the market and that, by removing the CQC’s responsibility and replacing it with an accreditation process through the UKAS, they will achieve the agility in the market that is required, alongside rigorous safety standards.

I say at once that I am a long-standing admirer of the UKAS, but it is reasonable to ask whether it has the expertise to undertake this important task. Under the CQC, providers of testing services were required to meet the fundamental standards of quality and safety set out in the 2014 regulations. The CQC monitors the quality, safety and effectiveness of care and can take action when it identifies that people using services are at risk of harm. How much of this is UKAS going to be able to do? Does it have the expertise and capacity to do it? What happens if there is a problem? Who is able to intervene and stop the service?

I also ask the Minister about timing, and the three stages he referred to. Clearly, one of the concerns is that the current process takes too long. I note from the UKAS website, which I was referred to by the Library, that it indicates a normal lead-in time of approximately three months to arrange the first assessment visit. Will that apply in this case?

Finally, could the NHS be contracting with the private organisations covered by the regulations? The Minister will be aware of the NAO report a couple of weeks ago on the £8 billion of contracts awarded by the Government using emergency procurement regulations. It found specific examples where there was insufficient documentation on key decisions and actual conflict of interests had arisen, which diminished public transparency. If the public sector could procure those private services, can we be assured that the contractual process will be rigorous?

My Lords, I thank my noble friend for his clear explanation of the two SIs. Like the noble Lord, Lord Hunt, I completely understand that there is urgency in trying to ensure that we have adequate but safe testing capacity. I want to ask my noble friend a few questions in the time available.

First, I note that the instrument applies only to England. What is the position on testing in Scotland, Wales and Northern Ireland? Secondly, the Explanatory Memorandum says that it could take up to 10 weeks to register with the CQC if large numbers try to register at the same time. What timeframe does it take at the moment? Might the new system speed things up, and by how much?

The United Kingdom Accreditation Service end-to-end testing regime for Covid-19 will require extra resourcing, staffing and capacity, I assume. I wonder what budget has been set aside for that. We are told that the cost will be lower for the UKAS. Do we have an idea of how much might be saved by this alternative system? I believe that guidance will be issued for prospective providers. Could my noble friend give us an idea of when that guidance might come through?

I confess that I have some concerns about the potential quality control in the new system. Coming from the pensions world and having seen so many scams, I fear that we may be opening ourselves up for an opportunity for fraudsters to make a lot of money on these testing regimes. I note that much of the system is self-assessed, which does not fill me with enormous confidence that there will be the necessary medical director, clinical scientist or systems. How will it be monitored and enforced?

The 2014 regulations have a statutory review clause, but today’s regulations do not. Why is that? Might it be wise for them to do so, given that this is potentially such a large issue?

My Lords, it is a pleasure to associate myself with the comments just made by the noble Baroness about the risks of deregulation and self-regulation. We have seen a great deal of concerning and tragic events flowing from that in the building industry. However, my first question, of which I have given prior notice, addresses what follows from testing: self-isolation. The Minister himself is self-isolating today, and I wish him and his family all the best. It is very difficult for many people to do, for financial reasons, because of care responsibilities, or for other reasons. In recognition of that fact, the Government have brought in a £500 payment for people ordered to self-isolate, with the money paid through local authorities. I credit Martin Lewis’s MoneySavingExpert website for what I understand is its original research, published yesterday, in doing spot checks and identifying at least five local authorities where the allocation of money has run out. It is reported that therefore people are being told they cannot get a payment. Can the Minister confirm that? If so, do the Government plan to fix this as a matter of urgency?

On my second point, I appreciate the fact that the Minister took time to explain in his introduction how he saw the idea of a market operating in Covid-19 testing. I have problems with the whole idea of a market in healthcare, but at least it was outlined clearly. In that outline, he said that everyone should have access to affordable tests. The explosion in the use of food banks started before Covid-19 but has certainly increased. People are unable to afford to buy even food. It is clear that lots of people would not be able to afford the price of a Covid test that they might have very good reason to want. Will the Minister consider perhaps approaching the suppliers of these tests and seeing if they could supply some to each food bank in the land, so that they would be genuinely available to everyone who might have good cause to need them?

The noble Lord, Lord Randall, has withdrawn, so I call the noble Lord, Lord Bourne of Aberystwyth.

My Lords, it is a great pleasure to follow the noble Baroness, Lady Bennett, who is always incisive. I thank my noble friend the Minister for setting out the measures so clearly and I wish him and his family all the best in the difficult situation he finds himself in. His workload is massive and this added pressure is extraordinary.

There is a clear need for testing for Covid-19, as my noble friend has set out, and that will continue for some time, notwithstanding the very good news about vaccinations. I support the measures. It is important that there is an appropriate regime for accrediting those who are carrying out testing on a commercial basis, and I recognise that the existing Care Quality Commission system had gaps in it. But the regime that is applicable under the commission meant that some test providers were within the ambit of the commission and others were not, so that was difficult to navigate. The new system seems more streamlined and straight- forward. It is to be provided by a body that we know is effective, the UK Accreditation Service. It will reduce barriers but will ensure that testing is of high quality. We should all welcome that.

Notwithstanding that, I have some questions which may tie in with some that have already been asked. The first was raised by the noble Lord, Lord Hunt: does the UKAS have the resources, expertise and capacity to handle this? I seek some reassurance from the Minister in that regard. My second point relates to liability. As is referred to in the Explanatory Memorandum, there is to be liability for failing to comply with the obligations in the instrument, and I understand that. I am not sure whether this will apply to companies or just to individuals. If it applies to companies, will it also apply to company directors? What if there are repeated breaches? Is there a scale of fines that are to apply? I believe that a fine is applicable on summary conviction. Is that a repeated fine and does it escalate? I would be grateful for some guidance from my noble friend on the matter.

My Lords, I thank the noble Lord, Lord Bourne, who always makes very perceptive comments and asks piercing questions, and I thank the Minister for introducing these statutory instruments. I echo the feeling that he works very hard and now has an extra burden; I hope that his family will recover soon.

I understand why there is a need for private sector testing—the NHS simply cannot cope—but I have concerns about the risk that these instruments could enable widespread private sector testing. Too often during the course of this pandemic, we have seen the private sector as the first port of call, with massive contracts going, for example, to Serco and Deloitte. Deloitte, it should be remembered, was running the testing centre at Chessington World of Adventures. Perhaps it was in the spirit of adventure that it approached the task, but it came in for criticism after losing the test results of NHS staff.

I share concerns that the private sector will see this as a money-making opportunity and cut corners. Like the noble Lord, Lord Hunt, I wonder whether the UKAS has the scope to cope with policing the new burdens being placed on it. I echo the fears of the noble Baroness, Lady Altmann, that there will be scope for fraudsters to enter this market.

There was some consultation before these proposals were made, and we are told that the feedback was “largely” in favour. Can the Minister tell us the concerns of those who were not in favour and how they are being addressed? I think, for instance, that the BMA has grave concerns about this. While we are told that the list of gold-standard providers will be available on the government website, I wonder how the Government propose to make all those who want tests aware of this. Certainly, on my very brief attempt, I failed to find the information on the website.

Can the Minister address the issue of costs? Will there be an upper limit or will providers just be able to prey on those who are desperate for a test for various reasons?

The noble Baroness, Lady McIntosh, has withdrawn, so I call the next speaker, the noble Baroness, Lady Uddin.

My Lords, I express my good wishes to the Minister and hope his family gets well very soon. I thank him for the precise manner in which he laid out the two SIs for our consideration.

I share the concerns expressed by the noble Baronesses, Lady Bennett and Lady Altmann, and, like others, I do not share the Minister’s confidence that adequate safeguards exist to effectively monitor private companies —some of them at least—given the fiasco that was impactfully detailed by the noble Baroness, Lady Wheatcroft.

I have a couple of general points to make. On social care for children and adults living with disabilities and autism, it is being widely reported anecdotally and in the media that families and carers are suffering an intolerable burden without adequate support from organisations and local authorities which, because of serious budget shortfalls, are failing in their statutory obligations and to safeguard their duty to protect the most vulnerable who may be experiencing abuse and neglect. Noble Lords will be equally concerned to learn that organisations such as Barnardo’s, the NSPCC and Include Me TOO, which provide specific services for ethnic-minority children, are overwhelmed with demands for services, as many families have depleted resilience to cope and to navigate the new maze of inconsistent and inadequate access to their rightful services.

The Minister speaks with confidence about the critical importance of effective testing services being available to those who require them. My inquiries in my local area, particularly among Bangladeshi communities, continue to alarm me. Many of them remain confused about at what point to trigger testing and what options might be available to them, therefore overwhelming GPs and local hospitals. I have spoken about this in the House on a number of occasions, and to the Minister personally, because there is simply not enough information being relayed to the communities in a bilingual format. I have also spoken to the Minister about re-examining the messaging and what else might need to be done to ensure that there are proper, consistent and effective messages going out about what needs to happen and where the services can be accessed.

My Lords, the noble Lord, Lord Wei, has withdrawn, so I now call the noble Baroness, Lady Jolly.