Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the oral contribution of The Paymaster General of 5 January 2022, Official report, col 122 that we have been building UK manufacturing capacity and we have been doing so by signing contracts with more than 30 British based companies for the provision of £3.9 billion items of PPE, if he will state the (a) number and (b) proportion of PPE items which were (a) imported from abroad and (b) manufactured onsite for each of those companies.
Answered by Edward Argar - Minister of State (Ministry of Justice)
Of the 3.9 billion items ordered from United Kingdom-based manufacturers, 2.5 billion has been delivered. All 2.5 billion items have been manufactured in the UK.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the (a) number and (b) proportion of (i) PPE, (ii) lateral flow tests, (iii) PCR tests and (iv) other covid-19 testing equipment are that have been manufactured by UK based companies.
Answered by Edward Argar - Minister of State (Ministry of Justice)
The Government has ordered 3.9 billion items of personal protective equipment (PPE) from United Kingdom manufacturers. This represents 10.7% of all PPE ordered since the start of the pandemic. We are unable to provide the information requested for lateral flow device and polymerase chain reaction tests and other COVID-19 testing equipment as this information is commercially sensitive.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
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 the current delays facing UK Coronavirus Test Device Approval (CTDA) assessments; and what plans his Department has to expedite the backlog before the February 2022 review deadline.
Answered by Maggie Throup
The backlog of tests in the Coronavirus Test Device Approval (CTDA) process was due to insufficient evidence submitted by applicants. We have since worked with applicants on the additional information required and permitted further time to submit this evidence. On 7 February 2022, we updated the online guidance for applicants to provide greater clarity on acceptance criteria for the range of viral loads within samples. The majority of applications are now meeting these standards and the rate of approvals is increasing.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will publish the (a) details of applications submitted to the Coronavirus Test Device Approval process, (b) dates on which each application was submitted, (c) date on which the applicant company was informed of a decision and (d) whether the decision was positive or negative in each case.
Answered by Maggie Throup
We are unable to provide the information requested as it is commercially sensitive. The Department publishes details of approved tests including the date of the decision, on GOV.UK at the following link:
https://www.gov.uk/government/publications/covid-19-test-validation-approved-products
If an application is unsuccessful, the applicant can request that we reconsider the decision. Officials continue to work with applicants through this process and guidance is available at the following link:
https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Answer of 15 February 2022 to Question 119864, how many of the 25 per cent of approved devices from UK manufacturers, have a (a) CE marking; and (b) UKCA mark; and how many of those are registered to UK-based companies.
Answered by Maggie Throup
A valid CE or UKCA marking is required to attain Coronavirus Test Device Approvals (CTDA) approval. All approved devices from United Kingdom manufacturers have a CE marking. All applications for CTDA approval must be made from a place of business registered in the UK. As of 25 February 2022, 14 out of 31 applications approved were from manufacturers established in the UK. All were made from a place of business registered in the UK.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the proportion of (a) laboratory capacity to process covid-19 PCR tests and (b) contact centre capacity which was paid for has not been used.
Answered by Maggie Throup
We do not set utilisation targets for laboratories as this is dependent on public demand for polymerase chain reaction testing.
The contact centre aligns resources to the forecasted growth or reduction in positive cases across the country. As figures fluctuate daily it is not possible to predict the exact number of agents to meet utilisation targets. However, the performance of the contact centres is monitored. In January 2022, 62% utilisation on the Trace Service and 63% on the general public testing enquires line was reached.
The information requested on paid for laboratory capacity which has not been utilised could only be obtained at disproportionate cost. Between October 2021 and January 2022, the contact centre and 119 service did not use an average of 28% of paid time.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the utilisation targets are in respect of (a) laboratory capacity to process covid-19 PCR tests and (b) contact centre capacity; and whether those targets have been reached.
Answered by Maggie Throup
We do not set utilisation targets for laboratories as this is dependent on public demand for polymerase chain reaction testing.
The contact centre aligns resources to the forecasted growth or reduction in positive cases across the country. As figures fluctuate daily it is not possible to predict the exact number of agents to meet utilisation targets. However, the performance of the contact centres is monitored. In January 2022, 62% utilisation on the Trace Service and 63% on the general public testing enquires line was reached.
The information requested on paid for laboratory capacity which has not been utilised could only be obtained at disproportionate cost. Between October 2021 and January 2022, the contact centre and 119 service did not use an average of 28% of paid time.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the (a) number and (b) proportion of PPE items purchased or procured by the Government are that have been manufactured by UK based companies.
Answered by Edward Argar - Minister of State (Ministry of Justice)
The Government has ordered 3.9 billion items of personal protective equipment (PPE) from United Kingdom manufacturers. This represents 10.7% of all PPE ordered since the start of the pandemic. UK manufacturers have the capacity currently to meet the estimated future demand for PPE in the UK, for all categories except gloves.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what further steps he will take to tackle the backlog of applications which have been submitted to the Coronavirus Test Device Approval process.
Answered by Maggie Throup
Addressing the backlog is a priority, however most applicants did not initially provide evidence of the correct type or standard. We have provided feedback to applicants on what additional information is required to progress their application and allowed the appropriate time to provide it.
We have made improvements to the process that have seen an increased flow of applications to the final stages. These steps include increasing the number of scientific advisors to meet demand, as well as updating the online guidance for applicants on 7 February 2022 to provide greater clarity for acceptance criteria for the range of viral loads within samples. This should enable applications to move through the process more efficiently.
We will continue to work with stakeholders to identify opportunities to streamline the process.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent discussions his Department has had with the Medicines and Healthcare products Regulatory Agency on plans to streamline the approval process of UK-made covid-19 tests.
Answered by Maggie Throup
Approval of COVID-19 tests for private use falls under the Coronavirus Test Devices Approvals regulation (CTDA). The CTDA process is robust, only devices that meet the high regulatory standards are available to the British public. Medicines and Healthcare products Regulatory Agency were heavily involved from the start in setting these high-performance standards.
25% of approved devices are from United Kingdom manufacturers, however, it is important as a fair and neutral regulator of market access that all applicants are treated equally and the Government is working at speed to review applications for devices submitted via this process. We have increased the number of scientific advisors to meet clinical demand and speed up CTDA approvals. Discussions are ongoing about how to further align regulation to ensure it works best for industry and the public.