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

Lord Bethell Excerpts

Thursday 10th December 2020 Grand Committee

Moved by

[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.

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[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.

Motion agreed.