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* Medicines & Healthcare products Regulatory Agency FOI release FREEDOM OF INFORMATION REQUEST ON INNOVA LATERAL FLOW TESTS (FOI 21/728) Published 29 December 2021 © Crown copyright 2021

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit

nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 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-21728

27th July 2021 FOI 21/728 Dear Thank you for your information request dated 19 June 2021 asking us for all information relating to the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for

diagnostic use and to address the questions below. We have addressed each of your questions in turn. Are these tests the same ones that are being distributed for free to the general public

for twice weekly testing? Reply: The devices being distributed under the Exceptional use authorisation (EUA) granted to the Department of Health and Social Care DHSC (DEU/012/2020/003) are

COVID-19 Self-Test to detect infection in asymptomatic individuals are repurposed Innova/Xiamen Biotime Biotechnology Test Kits. Please see the list of medical devices given exceptional use

authorisations here:

https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-given-exceptional-use-authorisations Are

these the tests the same ones which are used for health care staff testing? Reply: The use of the test falls within the responsibility and control of the legal manufacturer, DHSC. We

recommend you could ask them for this information via the following link. Are these tests still being distributed throughout the UK since this was announced? Reply: Following a satisfactory

outcome of a review undertaken, MHRA extended the EUA for NHS Test and Trace lateral flow devices (LFD). Although Innova are the supplier of NHS Test and Trace LFDs, the Department of Health

and Social Care (DHSC) have taken on the responsibilities of the legal manufacturer for the products used in the UK. The distribution of tests is the responsibility of DHSC as the legal

manufacturer. How many of these tests have been distributed to date? Reply: Unfortunately, this information is exempt from release under section 44 of Freedom of Information (FOI) Act 2000.

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 DHSC, a business which continues to exist. The distribution of

these tests is the responsibility of DHSC. We recommend you could ask them for this information. How many of these tests were purchased and still remain? Reply: Unfortunately, this

information is exempt from release under section 44 of Freedom of Information (FOI) Act 2000. 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 DHSC, a business which continues to exist. The purchase of these tests is within the control of DHSC. We recommend you could ask them for this information. We

suggest 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 at:

https://www.gov.uk/government/news/oxford-university-and-phe-confirm-high-sensitivity-of-lateral-flow-tests 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: [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:

https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/ If you have any queries, please reply to this email. Yours sincerely Enquiries

Co-ordinator Devices Division Back to top