Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020
(4 years ago)
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Lord Bethell
That the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con) [V]
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.
There is currently a requirement in England to register with the CQC if you are involved in the removal of bodily cells, tissues or fluid samples or the analysing and reporting of these samples for Covid-19 testing. This requirement is subject to a number of exemptions, depending on the type of Covid-19 test sampling and analysis and on the entity undertaking the sample collection. This has resulted in inconsistent requirements for test providers, which have been a source of confusion. Test providers have emphasised the complexities surrounding entering the Covid-19 testing market and we have listened to them.
The first statutory instrument that I have laid before your Lordships will remove the requirement for Covid-19 testing providers to register with the CQC by exempting Covid-19 testing as a regulated activity under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. As the CQC is an English regulatory body, this does not apply in the other nations of the UK. These requirements will be removed, preventing confusion over the scope of regulations from causing restrictions in total testing capacity. It is imperative that a quality service is provided and testing capacity is not restricted; the change from CQC to UKAS will create an agile and robust regulatory environment.
The United Kingdom Accreditation Service, known as UKAS, is the sole national accreditation body in the UK, independent of, but appointed by, the Government. Accreditation by UKAS is the recognised gold standard for organisations offering test services. Since the beginning of the pandemic, we have been working with UKAS to ensure that Covid-19 test providers can access advice on quality assurance and become accredited. It has taken time to ensure that we get this right. Recognising this, and the urgent need for high-quality private testing, on 27 November my department and UKAS launched an adapted three-stage UKAS accreditation process for private test providers, to ensure that new and innovative providers can be accredited faster, without compromising on rigorous safety standards.
The second instrument that I have laid before your Lordships will require all providers offering test services on the English market to complete stage 1 of the UKAS accreditation scheme and attain UKAS applicant status from 31 December. After 31 December, new entrants to the market will be required to achieve UKAS applicant status before offering test services on the English market. The instrument also requires providers to achieve stage 2 UKAS appraisal and stage 3 UKAS accreditation statuses. Providers will need to complete stage 2 UKAS appraisal by 31 January 2021 or, if entering the testing market after 31 December, by whichever is later of 31 January 2021 or four weeks after gaining applicant status. Providers will then need to complete stage 3 UKAS accreditation by 30 June 2021 or, if entering the testing market after 31 December, by whichever is later of 30 June 2021 or four months after gaining appraisal status. Providers will be prevented from offering test services if they fail to meet these requirements. We have engaged closely with providers to ensure that these timelines are achievable.
Stage 1 UKAS applicant status requires applicants to self-declare that they meet 10 minimum standards, set by clinicians. Having gained applicant status, stage 2 UKAS appraisal requires test providers to demonstrate that they are progressing towards accreditation. The last stage, stage 3 UKAS accredited status, requires applicants to achieve full accreditation. As a result of the legislation that I have laid before your Lordships, test providers that provide tests commercially will be required to undergo this staged accreditation process. Employers that provide test services only to their own staff and organisations that supply tests at no cost will not be required to gain UKAS accreditation, although I would advise that they do so to ensure that their test services meet the highest possible standards. From 15 December, international arrivals will be able to opt in to “test to release” and all test services used for this purpose will be required to be working towards full accreditation.
Before I set out my final justification for these SIs, I must thank the JCSI, which scrutinised them so quickly. I will explain how the tests for the presence of antibodies are covered by these regulations. Current forms of tests for antibodies are not covered by existing CQC legislation and will not be covered by the UKAS legislation. As such, these regulations do not leave any regulatory gap for testing for antibodies that did not already exist. However, providers of tests for the presence of antibodies to Covid-19 can choose to apply for accreditation if they wish to do so.
Fundamentally, the new UKAS scheme will simplify the process of looking for a commercial test. Consumers will be able to identify providers capable of delivering a quality end-to-end test service, giving individuals and businesses the assurance they need. We strongly advise that consumers and organisations procure test services only from the gold standard providers which are on their journey to UKAS accreditation. They will be clearly listed on GOV.UK.
The legislation that I have introduced will simplify the testing landscape for test providers and regulate the market consistently, protecting consumers and helping test providers. I am enormously supportive of employers who have already chosen to begin testing their staff, but it must be done properly, using the right tests for the right purposes. These regulations will help employers and individuals to identify the right test services for their purposes and will help test providers to enter the market.
Finally, I apologise for not being with your Lordships in the Grand Committee this afternoon. I have been asked to isolate because a member of my household has tested positive. I am extremely grateful for noble Lords’ forbearance in this matter. I beg to move.
Lord Hunt of Kings Heath (Lab) [V]
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?
Baroness Altmann (Con)
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?
Baroness Bennett of Manor Castle (GP) [V]
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?
Secondly on the issue of markets, the purpose of trading in a market is generally to make a profit on the good or service provided. Given the clear high demand and need for Covid tests, how are the Government ensuring that windfall profits are not made? Indeed, I ask the Minister directly: what percentage profit does he consider it would be reasonable to make on a Covid test?
Finally, given that this statutory instrument is essentially a deregulatory one, how are the Government ensuring that the use and promotion of lateral flow testing, which has been reported in the real world to have up to a 50% false negative rate, is used appropriately? Clearly it can be useful at population level to identify asymptomatic infections, but does the Minister agree that it would be deeply dangerous if it was used to give people an all-clear to mix and mingle, with or without precautions?
The Deputy Chairman of Committees (Baroness Pitkeathley) (Lab)
The noble Lord, Lord Randall, has withdrawn, so I call the noble Lord, Lord Bourne of Aberystwyth.
Lord Bourne of Aberystwyth (Con) [V]
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.
Thirdly, I refer to a point made by my noble friend Lady Altmann about the cost of applications. I am not clear on how costly it was under the CQC system for applicants, and how costly it is going to be under the new system. I think that it will be cheaper, but perhaps my noble friend the Minister could give guidance on what those costs will be. With those considerations, I am otherwise supportive of what seems a very sensible move.
Baroness Wheatcroft (Non-Afl) [V]
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 Deputy Chairman of Committees (Baroness Pitkeathley) (Lab)
The noble Baroness, Lady McIntosh, has withdrawn, so I call the next speaker, the noble Baroness, Lady Uddin.
Baroness Uddin (Non-Afl)
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.
Finally, I hope the Minister’s department is collecting adequate data on the kinds of communities—particularly their ethnicities and age ranges—where there are serious gaps in both testing and services. It is high time that we have effective equality impact assessment of all these different SIs as well as the provisions that the Government are providing.
The Deputy Chairman of Committees (Baroness Pitkeathley) (Lab)
My Lords, the noble Lord, Lord Wei, has withdrawn, so I now call the noble Baroness, Lady Jolly.
Baroness Jolly (LD) [V]
My Lords, I welcome the Government’s move to introduce this legislation, which simplifies and standardises the regulation of private sector testing for Covid-19. The Minister’s introduction was most helpful and I hope that he manages to avoid the virus. For the asymptomatic who require a test and can afford it, making tests accessible and of a high standard is extremely important.
We have two pieces of legislation before us today. I turn first to the health protection regulations. This instrument is to ensure that all private providers offering Covid-19 testing services on a commercial basis in England provide services that are of a sufficiently high standard. It is designed to simplify the complex regulatory environment for Covid-19 testing. Under the proposal, the United Kingdom Accreditation Service would provide a national accreditation service on the wider aspects of testing, including the processing, analysing and reporting of tests. The SI imposes an obligation on providers to make an application to a three-stage scheme to ensure consistency of standards; to offer assurance to the public about the quality of private tests through UKAS; and to ensure that the testing organisation would get accreditation from UKAS.
The second SI removes all coronavirus testing from the CQC regulatory environment, as I outlined above. But let us be clear: when anyone has Covid-19 symptoms, or has been asked to take a test by the local council, there are no problems. They can go the testing station or apply for the testing kit and there will be no cost. The free testing service is not for proof of freedom from Covid for travel or other purposes, such as being sure that you are safe to mix with friends and family at Christmas.
These tests have to be purchased privately and I wonder what their margin is. According to Which? last week, the going rate for a private test from a high street pharmacy is about £120. If a negative test is a prerequisite for a flight or something you feel you should do to make a family Christmas safe, the private sector is your only option, but for many, of course, that is not financially possible and so risks may be taken. Certainly, when our children were small, there was no way we could have afforded the equivalent of nearly £500; likewise if you had hoped to get away over the Christmas holidays for some sun. I note that the CMO has said that he is anticipating a surge in cases after Christmas. Testing might be nice to have, but masks will be essential.
It looks as though one of the beneficiaries of these SIs could be pharmacies. I have two points that I would like clarification on from the Minister. First, the Health Secretary has noted that 25% of individuals taking NHS tests were not eligible. This legislation seeks to enable private testing to complement government testing and reduce pressure on test and trace. Could the Minister please provide more detail on this? Specifically, how does increasing the accessibility of private sector testing allow the Government to shift to a wider testing strategy and, crucially, the testing of asymptomatic individuals?
Secondly, someone who cannot afford a private test from a high street pharmacy and cannot access NHS testing will be left in isolation, often without appropriate financial support. In general, we will always be limited by capacity to some extent, but it is vital that we move away from the current model of testing only those with symptoms. Mass testing in Liverpool showed that testing those without symptoms can help us to interrupt the flow of transmission. I would like reassurance from the Minister that encouraging private sector testing will not create or exacerbate inequalities.
A well-off asymptomatic individual may be able to end a period of isolation and return to work or travel by paying for a private test. As with all areas involving communication with the public, we have to be aware that an Anglo-Saxon approach is probably not ideal. This is a contributing factor to the low isolation compliance—a huge challenge in controlling the virus. What is the wider strategy to ensure that the NHS and Lighthouse Labs work in harmony so that those who most need tests can access them free of charge?
Of course, I appreciate that working with the private sector is vital in this pandemic and making the pathway to test provision simpler may increase competition and reduce prices. This would: allow providers to enter the market more quickly and at lower cost; provide more comprehensive oversight of the entire market; and ensure quality of testing standards. In addition,
“novel, non-clinical testing technologies and methods”
would not need to be individually exempted from regulation.
I will finish where I started: for those who are asymptomatic who require a test and can afford it, making tests accessible and of a high standard is extremely important. However, we must be wary of exacerbating inequalities through access to testing. How do the Government intend to prevent this? I look forward to the Minister’s comments.
Baroness Thornton (Lab)
My Lords, it is quite clear that the smaller first statutory instrument is a tidying-up regulation and I thank the Minister for introducing it. The other regulation is, as the Minister put it, about developing a private market for testing. The questions that have been addressed to him in this short debate will have told him that there are some concerns about how that works.
My first question is: why is the CQC not the obvious body to do this? What has led to it being the UKAS? The time it takes to be accredited does not seem that different.
That leads to my next question, which was raised by my noble friend Lord Hunt: what additional resources and staffing has the UKAS been given to carry out this new responsibility? I looked at its website. Obviously, it is a creditable and important body. I am not undermining it at all, but I am questioning it taking on this new responsibility, which involves more expertise and more funding. Because it is a public health issue we are talking about here—the spread of Covid—what are its responsibilities when somebody gets a negative result? What happens when someone is infected with Covid? I would like to know what responsibility is being placed on the UKAS for it to place on the private sector deliverers of this service when they test someone who tests positive for Covid? It seems absolutely vital that that person is placed in the test and trace system. Can the Minister explain to the Committee what the “trace” bit of this is?
The noble Baronesses, Lady Wheatcroft and Lady Altmann, raised the potential for fraud and testing scams. How will the Government make the public aware of the need for test providers to be properly accredited? Also, how will they ensure, as part of the monitoring and regulation, that the certificates that are issued cannot be falsified or sold on, and what are their powers to intervene if they suspect or it is reported that that is happening? It is inevitable that some investigative journalist or programme will indeed try to do that in order to test the system. If it is found wanting, it will be a very serious undermining of what should be safe private testing.
There are a number of commercial providers offering Covid-19 “fit to fly” tests in the UK. As other noble Lords have mentioned, Which? found that the costs varied considerably, from £60 at London’s Gatwick Airport drive-through test—the cheapest test—up to £214 at a clinic in London. Of course, for a family of four going on holiday, that is a significant amount of money. Is there an intention to cap the price of these tests to make sure that individuals and families are not priced out? I think it is important for the Minister to explain the link and relationship between public sector procurement of these tests and the private services. We now have a long list of procurement problems—to put it mildly—in the testing and tracing regime and possibly billions of pounds of public money have been wasted; we will find out. We do not want to add to that with this new regulatory framework.
Lord Bethell (Con) [V]
I thank noble Lords enormously for an incredibly thoughtful discussion and I will seek to answer as many of their piercing and thoughtful questions as I can. If I miss any I will be pleased to write to noble Lords to clear up any loose ends. I will forgo the normal warm words at the beginning of such a speech and move directly to addressing the questions raised by noble Lords.
It is absolutely vital, as we open up our economy, that NHS supplies are saved for the situations where they are most needed. That is the principle behind what we are doing here today. To be clear: we are continuing to massively upgrade our commitment to testing. The PCR testing capacity for clinical and symptomatic testing is now reaching towards 800,000 a day—a colossal number—and the turnaround times have come down dramatically. In my household’s case, the test was taken at lunchtime yesterday and the result came at 7 am today—a phenomenal logistical achievement. We are also committed to the kind of community testing that the noble Baroness referred to, with the testing of asymptomatic individuals using technology such as the lateral flow devices that noble Lords will be aware of. This is exemplified by, but not limited to, the kind of testing in universities and schools that we have been piloting this autumn and will be rolling out in a very big way over Christmas.
As I have said before, we are investing massively in NHS testing, free at the point of use and available free of charge to all those who meet the use cases defined by the CMO. To ensure that this is possible, we need to enable the provision of new and innovative testing programmes that are as reliable and effective as possible. However, the NHS cannot possibly have pressure put on it to provide every test that every person in every part of this country wants at every time of the day. That has never been the case in this country and cannot be the case in the future. If tests are needed that are outside the use case or if someone is seeking to enable activities that fall outside the responsibility of our public health regime, it is right that those tests are sought from outside the NHS. It is therefore right that we seek to regulate the provision of those tests by the private sector.
The legislation that I have set out will ensure this, providing public confidence in testing and supporting private providers to enter the market. As I have set out, we need to create an agile regulatory environment for test providers, and we can do this by removing all CQC regulatory requirements for test providers, replacing them with the gold standard UKAS accreditation for commercial test providers. It is not our intention to cap the price, but it is our expectation that, given the billions of Covid tests now being manufactured around the world, the price will fall dramatically, and it is our intention to ensure that the quality meets clinical standards.
These measures will simplify the complex regulatory system for Covid-19 test providers; simplify the process around looking for a commercial test; and give individuals and employers essential assurances over the tests they procure. In response to the noble Lord, Lord Hunt, and my noble friend Lord Bourne, accreditation by the UKAS is the recognised gold standard for organisations that offer test services. My officials have worked really closely with colleagues at the UKAS to ensure that the accreditation scheme for Covid-19 test providers is as agile as necessary to deal with this growing market. The adapted three-stage approach is a direct result of this, ensuring that new and innovative providers can be accredited in a timely fashion, while preserving the UKAS gold standard. My officials will continue to work with the UKAS to ensure that this process is as seamless as possible, that test providers are given the support that they require to move through the scheme, and that correct enforcement procedures are in place.
Regarding contracting private industry to supply testing services, I hope that I will not shock either the noble Lord, Lord Hunt, or the noble Baroness, Lady Bennett, if I tell them that we are already engaged with the private sector in the purchasing of healthcare services for the NHS in the UK—not least in the provision of primary healthcare, which is conducted by the private sector in the form of GP practices, and through social care. That is also true in testing services. Time and again, throughout this pandemic, the private sector has shown that it has a critical role to play. While I note the comments of my noble friend Lady Wheatcroft, my experience of private-industry contractors has been largely positive; where there have been problems, we have to look at the whole partnership of government, universities, NHS and private industry for responsibility, not seek to scapegoat any particular party in this national collaboration. It is vital, as we look to open up our economy, that NHS Test and Trace supplies are focused where they are needed most. To ensure that this is possible, while utilising new testing innovations, the Government are supporting the development of the private testing market. To do this, we are bringing forward the regulations that I have laid before noble Lords today.
In response to the noble Lord, Lord Hunt, and to my noble friend Lady Altmann, I make it clear that the existing lengthy and costly on-boarding process is one reason for introducing this more agile system. The existing system is suited for major complex laboratories, many of which have been around for many years, and new entrants to the market are rare. We hope to have a more agile regime that will encourage innovation, but I will be glad to write to noble Lords with details of the intended costs.
My noble friend Lady Altmann is absolutely right to be concerned about fraud. She is right that there is a self-assessment at the beginning of the process, which is quicker and cheaper, to encourage new entrants and to avoid bottlenecks as this industry scales up. However, this is quickly augmented by a mandatory requirement to follow a rigorous on-boarding process with full administration. I am convinced that this will provide the necessary supervision of this industry, although I take her comments seriously and we will keep a careful eye on this threat. To answer my noble friend Lord Bourne, the test providers will be prevented from offering services if they do not have the right authorisations. If they break the rules, there are substantial—unlimited, I think —fines set by magistrates and applied to the company to ensure enforcement.
The legislation that I have introduced will simplify the regulatory landscape for test providers and regulate the market consistently. I thank Covid-19 test providers for their pivotal work at this time. We encourage the development of these sorts of test services in order to reduce pressure on the NHS and ensure that the test and trace programme can focus on situations where it is needed most; but it must be done properly, using the right tests, for the right price and the right purposes, and with the right enforcement regime. I beg to move.