Freedom of Information request on Innova lateral flow tests (FOI 21/847)
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-21847
26th July 2021
FOI 21/847
Dear
Thank you for your email of 17 June 2021 in which you requested as follows:
The decision taken to extend the use of the Innova LFT test requires the publication of all the data supporting your decision - please provide me with that data.
We have fully examined the concerns raised by the FDA and their applicability to the products being supplied by NHS Test and Trace in the UK. Following our normal process to investigate any product concern, the MHRA immediately began reviewing all available information. A full risk assessment was undertaken by the Department of Health and Social Care (DHSC) as a legal manufacturer of the lateral flow devices in the UK and the MHRA were satisfied with the assessment and any action proposed.
Further information can be found on our website:
You may be aware that DHSC/Test and Trace have published data on test performance:
https://www.gov.uk/government/publications/lateral-flow-device-performance-data
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 Innova Medical Group Inc a business which continues to exist.
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: [email protected].
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:
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre