Freedom of Information request on the MHRA exceptional use authorisations issued to DHSC and Zhejiang Orient Gene Biotech for their COVID-19 rapid antigen self-tests (FOI 21/-772)
Published 27 April 2022
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3rd August 2021 FOI 21/772
Dear
Thank you for your information request, dated 5th July. In your email you referred to the MHRA exceptional use authorisations issued to DHSC and Zhejiang Orient Gene Biotech for their COVID-19 rapid antigen self-tests. Specifically, you requested information on
• when these 2 manufacturers applied for, and were granted exceptional use authorisations, and • how many other manufacturers of Covid-19 Antigen Self-Test kits applied for exemption under the exceptional use scheme but were denied an exemption.
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, you may find further information using the link below which comprises information on all devices for which MHRA had issued an exceptional use authorisation:
List of medical devices given exceptional use authorisations - GOV.UK (www.gov.uk)
We recommend that you contact the legal manufacturer directly with regards to any information pertaining their products.
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