Appendix 1: Correspondence: Health Protection (Coronavirus, International Travel) (England)(Amendment) (No. 9) Regulations 2021 (SI 2021/223)
Letter from Lord Hodgson of Astley Abbotts, Chair of the Secondary Legislation Scrutiny Committee, to Lord Bethell, Parliamentary Under Secretary of State at the Department of Health and Social Care
I am writing to you in my capacity as Chair of the House of Lords Secondary Legislation Scrutiny Committee. This week, we considered these Regulations but could not complete our scrutiny because of insufficient information.
We were, in particular, dissatisfied that the Explanatory Memorandum (EM) gives no background on the rationale for transferring mandatory coronavirus testing of travellers to the private sector, or the steps that are needed to be taken before it can happen. We therefore had no means of assessing the impact of the delay that the instrument enables, nor what the consequences might be, for example, whether state resources will continue to be used that had been previously earmarked for other purposes.
We would also like to know how information from private tests will be integrated into the Test and Trace system, what percentage of travellers are currently being contacted by the Isolation Assurance Service, what percentage are being passed to the police for investigation of non-compliance, and whether the move to private tests will alter those levels.
We asked your department why the requirement for laboratories to notify technical information about certain samples was extended to 15 March 2021 (regulation I 0). The response we received offered little clarification:
“This requirement is being delayed to allow more time for PHE to onboard laboratories to the complex process of uploading BAM sequencing files when reporting the viral genome for positive cases.”
We would therefore be grateful if a fuller and more accessible explanation could be provided, including information about the context, the reason for the delay and its consequences. Does this delay in “onboarding laboratories” mean, for example, that data about variants of concern will be delayed or not passed to the authorities who need to monitor those infected?
10 March 2021
Letter from Lord Bethell to Lord Hodgson
This letter provides further detail in response to your letter of 10 March in which you expressed your dissatisfaction that the Explanatory Memorandum (EM) for the Health Protection (Coronavirus, International Travel)(England)(Amendment)(No. 9) Regulations 2021 (SI 2021/223) gave insufficient background on the rationale for allowing the private sector to deliver mandatory coronavirus testing of travellers.
The move to introduce private sector testing of travellers is, in part, in order to safeguard NHS T&T capacity for clinical priorities. It is also intended to encourage market innovation, offering choice to the consumer and enabling demand to expand the market’s capacity, as well as encourage a dynamic diagnostics industry. Travel is a discretionary activity and international arrivals are therefore required to pay for their testing.
Minimum standards are established in legislation for private providers of day 2 and day 8 testing for international travel. These cover test diagnostics and genome sequencing, including independent validation of test performance, the competence end-to-end testing delivery through UKAS accreditation and data reporting. Where a private provider identifies positive test results from international arrivals’ day 2 tests, the positive sample must be genome sequenced, with the standards for genome sequencing also set.
You queried the impact of the delay that the instrument enables on the demand for privately provided testing. Based on the Corporate Travel Management (CTM) quarantine and test bookings data, in the period 15 February to 13 March inclusive there were 5,158 red-list arrivals and 237,957 amber-list arrivals. Based on prior volumes, the private sector will be able to deliver testing to 98% of arrivals. Depending on consumer preference and market pricing, private providers are likely to deliver a significant proportion of this potential market.
You ask how the information from private tests will be integrated into the NHS Test and Trace system. The provider must have a system in place for reporting positive, negative and inconclusive test results cases in accordance with their obligations under the Notification Regulations and the International Travel Regulations. This includes data fields for the test result, personal data for the purposes of contact tracing and international travel data fields for the purposes of disease surveillance. The reporting of results, including the identification of Variants of Concern, is fully integrated into NHS Test and Trace systems. As for NHS Test and Trace tests, positive results from privately provided tests trigger contact tracing and the identification of a variant of concern triggers enhanced contact tracing. Privately provided testing is also integrated into the disease surveillance systems.
You ask whether privately provided testing will impact on the compliance and enforcement approach. All international arrivals must book a testing package before travel, and this booking is checked by Border Force. All international arrivals are called by the IAS service to check that they are quarantining and completing mandatory tests, unless they are claiming a sectoral exemption from testing. Allowing private providers to deliver tests does not alter the compliance approach for mandatory testing or the approach to applying penalties for non-compliance.
You asked why the requirement for laboratories to notify technical information was extended to 15 March 2021 (regulation 10). This was delayed to allow more time for PHE to onboard laboratories to the upload of BAM (Binary Alignment Map) files. A sorted BAM file contains ‘reads’ aligning to the SARS-CoV-2 reference genome and is a recognised format for storing genome sequences. The reporting of BAM files will allow for the identification of new, unknown variants and quality assurance of the genome sequencing undertaken by private providers. Reporting of a BAM file became a requirement on the 15 March. This did not delay the reporting of identified and known Variants of Concern, which can already be reported by private providers through existing systems. It also would not have delayed enhanced contact tracing were any known Variants of Concern to have been identified by a private provider in this period.
15 March 2021