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

Lord Allan of Hallam Excerpts

Monday 27th November 2023 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

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.

[Lord Allan of Hallam (LD)]

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.