Freedom of Information request on a copy of all correspondence shared between the MHRA and the Notified Body GMED, concerning the safety of Allergan Biocell breast implants from 2006-December 2018 (FOI 21/1326)
Published 31 May 2022
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FOI 21/1326
21st December 2021
Dear,
Thank you for your information request, dated 17th December 2021, where you asked for “a copy of all correspondence and/or reports, and/or data-analysis, shared between the MHRA and the Notified Body GMED, concerning the certification, safety and/or performance of Allergan Biocell breast implants for the period from 2006-December 2018”
Unfortunately, the information is exempt from release under section:
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 Allergan, 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 have a query about the information provided, please reply to this email.
Yours sincerely,
Devices Queries