Freedom of Information request on adverse reactions reported from B.Braun: HISTOACRYL BLUE / LAPFIX / PROSET OFX (FOI 21/1128)
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-adverse-reactions-reported-from-bbraun-histoacryl-blue-lapfix-proset-ofx-foi-211128
12th October 2021
FOI 21/1128
Dear
Thank you for your email dated 11 October, where you asked “Has the MHRA’s received any yellow cards over patient harm related to “B.Braun: HISTOACRYL BLUE / LAPFIX / PROSET OFX” since December 2020 to date?”.
Unfortunately, the information is exempt from release under section 44 of Freedom of Information 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:
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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.
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relates to the affairs of B. Braun, a business which continues to exist.
On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.
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.
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
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU