Freedom of Information request on the complaints of dehydration to the MHRA and Hollister (FOI 22/457)
Published 31 May 2022
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FOI 22/457
2nd March 2022
Dear
Thank you for your information request, dated 08/02/2022, where you asked for how many other customers complained of dehydration to the MHRA and to Hollister between 6 months before and after your complaint.
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:
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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 Hollister, 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.
The MHRA takes a risk proportionate approach. From our communication with the manufacturer, as well as a review of our own data, at this moment in time we do not have enough robust evidence to suggest that the instructions need to be amended. As you mentioned in your email that you are aware of others experiencing the same issue, I would ask that you encourage these individuals to report this to MHRA via our Yellow Card reporting site. We use adverse incident reports to help us with identifying trends in data and this can, in some situations, provide us with more leverage when working with manufacturers to initiate change. This data is regularly reviewed by subject matter experts and investigations are undertaken where necessary.
I would like to reassure you that we will be continuing to monitor the situation and the information that you have provided to date will feed into any future investigations for this device so I would like to thank you for providing this.
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 Experience Centre