Aviva Otte, Oscar Barker and Yousef Al-Kharboush
15 Nov 2024 · Coroner Julian Morris · London Inner (South)
The coroner's concerns
1. lack of mandatory reporting of adverse events by section 10 entities
“There is no requirement for a section 10 exempt entity to report any of its findings to the MHRA or indeed to other Trusts or the industry in general if an adverse event occurs”
2. commercial organisations may not share risk information
“the same may also be true of commercial organisations but they have the power of the MHRA controlling and effecting recalls and actions and the wider dissemination of information”