FOI release

Freedom of Information request on documentation used to approve testing kits (FOI 21/858)

Published 27 April 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-11-october-2021/freedom-of-information-request-on-documentation-used-to-approve-testing-kits-foi-21858

13th October 2021

FOI 21/858

Dear

Thank you for your Freedom of information request dated 27 July, where you requested the following information:

  1. who supplied the MHRA with the required documentation so that a full and in-depth study could be performed on the product prior to the issue of the emergency use approval?

  2. please supply the full title and reference numbers of the documents in the MHRA’s possession supplied by the manufacturer and that were used to justify the issue of the emergency use approval
  3. Please supply all paperwork including e-mails, minuted meetings and telephone calls in the MHRA’s possession of internal MHRA discussions and externally with the DHSC that relate to the issuing of the emergency use approval for the test kits in question

With regard to question 1, we are not able to supply the name of an individual as under Section 40 of the Freedom of Information Act 2000 (FOIA).

Section 40 - Personal information: information is exempt if it contains personal data which would identify a living person.

  • MHRA is satisfied that the release of an individual person’s name, their job title or function constitutes personal data which would identify a living person.

We reconfirm that the application for the exceptional use authorisation was made to MHRA by Department of Health and Social Care (DHSC), the legal manufacturer of the device.

Unfortunately, the information you have asked for in questions 2 and 3 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 Department of Health and Social Care (DHSC) and Xiamen Biotime Biotechnology Co Ltd businesses which continue 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: info@mhra.gov.uk.

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 a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

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 at:

Information Commissioner’s Office

Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Kind regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

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