FOI release

Freedom of Information request on Department of Health and Social Care lateral flow tests (FOI 21-725)

Published 29 December 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-july-2021/freedom-of-information-request-on-department-of-health-and-social-care-lateral-flow-tests-foi-21-725

20th July 2021

FOI 21/725

Dear

Thank you for your information request dated 25 June 2021 asking us for:

  1. The technical documentation provided to the MHRA by the Department of Health and Social Care (DHSC) for the approval of the DHSC manufactured lateral flow device tests and purchased on behalf of NHS Test and Trace that supplies information and information on studies showing it’s accuracy on asymptomatic persons and/or persons with a low viral load

  2. The technical documentation and/or independent studies showing the Xiamen Biotime Biotechnology Co Ltd manufactured lateral flow device tests with the Department of Health and Social Care listed on the MHRA approval as the manufacturer and purchased on behalf of NHS Test and Trace has been proven to provide comparable and accurate results from those swabs taken by non-medically trained persons that are self-taken and unsupervised compared to swab taken and/or supervised by medically trained persons registered as per the targeted product profile requirements: https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-point-of-care-sars-cov-2-detection-tests

  3. The technical documentation showing the difference between the Xiamen Biotime Biotechnology Co Ltd manufactured lateral flow device tests with the manufacturer stated as Innova and the Xiamen Biotime Biotechnology Co Ltd manufactured lateral flow device tests with the Department of Health and Social Care listed on the MHRA approval as the manufacturer and purchased on behalf of NHS Test and Trace are materially different in manufacture and composition.

Unfortunately, the information you have asked for is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA).

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

  • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

  • relates to the affairs of Department of Health and Social Care (DHSC) a business which continues to exist.

MHRA recommend that you could contact the manufacturers, in this instance the Department of Health and Social Care (DHSC) and Xiamen Biotime Biotechnology Co Ltd., with regards to information about the manufacture and composition of their lateral flow tests. You may find of interest the performance evaluation data published on the Government website: https://www.gov.uk/government/news/oxford-university-and-phe-confirm-high-sensitivity-of-lateral-flow-tests. This contains a link to an evaluation report. You may also find helpful the lateral flow device performance data published by DHSC which can be found at Lateral flow device performance data - GOV.UK (www.gov.uk).

The target product profile document you referenced was developed to assist manufacturers to design and deliver tests that might be useful in support of the UK COIVD-19 testing strategy for tests used at point of care. How closely a product matches the profile may inform procurement, but it is not a regulatory requirement to meet this specification.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/

If you have a query about the information provided, please reply to this email.

Yours sincerely,

Enquiries Co-ordinator

Devices Division

Medicines and Healthcare Products Regulatory Agency

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