Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they have made towards developing (1) rapid, and (2) accurate, PCR testing infrastructure to control infections and protect patients in (a) NHS, and (b) private hospitals.
Answered by Lord Kamall
In National Health Service hospitals, rapid polymerase chain reaction (PCR) testing is in place to support the urgent testing of patients. Free symptomatic testing continues to be provided for patients in hospital for whom a test is required for clinical management or to support treatment pathways; individuals who live or work in high-risk closed settings in patient facing roles where infection needs to be identified quickly to minimise outbreaks; and individuals whose immune system means they are at higher risk of serious illness from COVID-19 who are eligible for anti-viral medication or other treatments. People in this group will be contacted directly and automatically receive tests for use should they have COVID-19 symptoms.
Hospitals also use rapid lateral flow device testing where appropriate, which can be used in emergency departments as part of the early decision assist test pathway. The UKHSA does not provide PCR testing to private hospitals as part of the testing regime.
Asked by: Feryal Clark (Labour - Enfield North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of trends in the level of covid-19 tests available on the market that have not been approved by his Department.
Answered by Maggie Throup
Reports of non-compliance with the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 remain consistently low. All reports of non-compliant COVID-19 tests are reviewed by the Medicines and Healthcare products Regulatory Agency and relevant regulatory action taken where necessary.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the (a) Government, and (b) UK Health Security Agency are taking to ensure the Coronavirus Test Devices Approval process is held to the same operational standards of (i) transparency and (ii) communication with applicant companies as internationally recognised regulatory processes.
Answered by Maggie Throup
Throughout the Coronavirus Test Devices Approval (CDTA) process applicants have access to dedicated communication, review and complaint channels. Following the desktop review, applicants receive a report detailing whether the application guidance has been followed and if the threshold performance for specific technology has been met. Approved tests are also published on a register on GOV.UK and if an application is unsuccessful, the applicant can request that the Department reconsiders its decision.
Officials work with applicants to support them through the process and online guidance is provided on how to apply for the CTDA and the information required at each stage. The guidance is regularly refined, in line with standard regulatory process in the United Kingdom and internationally. We will review the CTDA process at the end of 2022 and consider its efficiency and transparency, including lessons learned from international regulators.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to work with the diagnostics industry to (1) solicit, and (2) implement, feedback on the (a) efficiency, and (b) transparency, of regulatory bodies as part of ongoing reviews of the Coronavirus Test Device Approvals process.
Answered by Lord Kamall
The UK Health Security Agency regularly engages with the diagnostics industry in the United Kingdom and others on the Coronavirus Test Device Approvals (CTDA) process. We will review the CTDA process due by the end of the year and consider its efficiency and transparency.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the income generated from desktop review fees submitted by companies applying to the Coronavirus Test Devices Approval (CTDA) process has been reinvested to ensure that the newly introduced regulator operates proficiently and at a high standard.
Answered by Maggie Throup
The Coronavirus Test Devices Approval (CTDA) process operates on a cost recovery basis and does not generate any income from its desktop review fees, in excess of expenses incurred in the carrying out of its core duties. All revenue generated is offset against the cost of running the CTDA process.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether companies that paid the mandatory desktop review fee to submit an individual application to the Coronavirus Test Devices Approval process will be reimbursed if no outcome is given by the UK Security Agency before the 31 May temporary protocol deadline.
Answered by Maggie Throup
The fee is charged to assess an applicant test to ensure it is safe and of sufficient quality to enter the United Kingdom market. It is not related to the 31 May temporary protocol deadline therefore no reimbursement will be made.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they conducted a cost analysis before the implementation of the Coronavirus Test Device Approvals process; and how the desktop review fee amount for test applications was decided.
Answered by Lord Kamall
The Department’s online only impact assessment included a cost analysis and calculations on the implementation of the Coronavirus Test Device Approvals process. It is intended that this regulation should be cost neutral for taxpayers and as such, the Government recovers the costs from applicants, while ensuring fees are as low as possible. However, through engagement in a public consultation and with industry, we recognised concerns on ensuring smaller businesses can access the market. Therefore a discounted rate of 55% is offered, in line with taxation benefits for research and development spending offered to small to medium-sized enterprises. We have committed to review the policy at the end of 2022.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to address the reported bottleneck in the Coronavirus Test Device Approval process.
Answered by Lord Kamall
Current delays in the Coronavirus Test Device Approval (CTDA) process have been due to further information being sought from applicants during the validation process. However, to ensure applications meet the required standards, expert support has been provided by officials, with 60% of approvals being processed in the last three months.
The number of scientific advisors has also been increased to meet demand. Online guidance for applicants has also been updated to provide greater clarity for acceptance criteria for the range of viral loads within positive samples. Officials continue to work with applicants to provide support during the process and minimise any potential delays.
Asked by: Geraint Davies (Independent - Swansea West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will hold discussions with representatives of NHS Test and Trace on the use of the results of privately purchased covid-19 antigen tests to ensure that (a) the spread of covid-19 is tracked and (b) people who may have been in close contact with an infected person are alerted.
Answered by Maggie Throup
It has not proved possible to respond to the hon. Member in the time available before Prorogation.
Asked by: Alan Brown (Scottish National Party - Kilmarnock and Loudoun)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the total cost of the purchase of covid-19 PCR test kits has been to date; and how many of those kits have been purchased.
Answered by Maggie Throup
The UK Health Security Agency (UKHSA) is unable to provide the information requested on the cost of purchasing of COVID-19 polymerase chain reaction (PCR) tests as this information is commercially sensitive.
PCR test kits are comprised of several components which are individually purchased, prior to assembly. Between April 2020 and March 2022, the UKHSA purchased materials which were manufactured to make 154 million test kits.