FOI release

Freedom of Information request on Innova lateral flow tests (FOI 21/763)

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-26-july-2021/freedom-of-information-request-on-innova-lateral-flow-tests-foi-21763

27th July 2021

FOI 21/763

Dear

Thank you for your information request dated 4th July 2021 asking us for:

  1. The technical documentation supplied to the MHRA from both the previous manufacturer (Innova) and the current manufacturer (the Department of Health and Social Care) showing the differences 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.
  2. the justifications supplied by the DHSC and used by the MHRA to allow the repurposing of the Innova/Biotime Test Kit

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) and Xiamen Biotime Biotechnology Co Ltd businesses which continue 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.

The MHRA requirements to apply for an Exceptional Use Authorisation can be found at: For industry and manufacturers: COVID-19 tests and testing kits - GOV.UK (www.gov.uk)

You be interested to see 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)

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

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

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 at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Service Centre

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