Freedom of Information request on the special use of DHSC COVID-19 self-test kits (FOI 21-589)
Published 13 August 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-21-june-2021/freedom-of-information-request-on-the-special-use-of-dhsc-covid-19-self-test-kits-foi-21-589
23rd June 2021
Dear
Thank you for your information request, dated 28th May. In your email you referred to the MHRA authorisation letter dated 22 December 2020 for the special use of DHSC COVID-19 self-test-kit’ and requested information regarding the intended purpose and the stated performance, and you also asked us to provide you with a copy of any assessment which MHRA holds.
Unfortunately, the information is exempt from release under Section 44:
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 businesses which continues to exist.
On that basis we are satisfied that section 44 of FOI Act apply, and the information is exempt from release.
However, we can confirm that the intended purpose of the COVID-19 Self-Test (Repurposed Innova/Biotime Test Kit) is to detect infection in asymptomatic individuals. Further information is available using the links below:
•List of medical devices given exceptional use authorisations - GOV.UK (www.gov.uk)
•MHRA issues exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device - GOV.UK (www.gov.uk)
We recommend that you contact the legal manufacturer directly with regards to these requests who may be able to offer you more information.
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 Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU