FOI release

Freedom of Information request on the Lateral Flow Tests detecting SARS-CoV-2 (FOI 22/007)

Published 31 May 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-7-february-2022/freedom-of-information-request-on-the-lateral-flow-tests-detecting-sars-cov-2-foi-22007

FOI 22/007

11th February 2022

Dear,

Thank you for your information request, dated 3 January and our sincere apologies for the delay in our response as we are currently experiencing high volumes of queries. In your request you asked for

  1. “I would like to know what evidence MHRA holds or has reviewed to demonstrate that the Lateral Flow Devices licensed for use on the British public to detect SARS-CoV-2 infection do not detect other coronaviruses. I would like this evidence presented by manufacturer, device/ test name, licensed use, and license start and end dates.
  2. If available I would also like to know the volume purchased or deployed.
  3. I note that the Instructions for Use of the Surescreen rapid antigen lateral flow test, which has been purchased en masse by DHSC, states that ‘Positive results may be due to current infection with acute non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E.’ This information is available via this hyperlink: https://www.primarycaresupplies.co.uk/pub/media/mageplaza/product_attachments/attachment_file/s/u/surescreen_instructions_3.pdf

I would also like to know if MHRA or DHSC were privy to that information when making the decision to purchase the products, or license them for use in the detection of SARS-CoV-2.”

Unfortunately, the information asked in question 1 is exempt from release under section 44 of the 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 multiple businesses, which continue to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

The information asked in question 2 is exempt from release under section 41 of the FOIA.

Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.

You may wish to contact the manufacturer of the specific test kits for this information.

The information asked in question 3 is also exempt from release under section 44 of the 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 Surescreen Diagnostics, a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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

Yours sincerely,

MHRA Customer Experience Centre

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