Freedom of Information request on follow ups for deaths reporting through the yellow card system (FOI 21/941)
Published 25 February 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-6-september-2021/freedom-of-information-request-on-follow-ups-for-deaths-reporting-through-the-yellow-card-system-foi-21941
8th September 2021
FOI 21/941
Dear
Thank you for your email dated 11th August 2021, whereby you requested the following information:
• How many of those deaths on your Yellow Card reporting system have you sought permission to follow up?
• How many did you actually get permission to follow up?
• Of the above, for how many were post-mortem details available?
In response to your first and second question, to submit a Yellow Card report, we require certain personal information. We ask for the reporter’s name and contact details so that we can get in touch if we need more information on their case. This information is outlined in our Privacy Policy which can be viewed via this link Yellow Card Scheme - MHRA. Therefore, the MHRA does not need to seek permission to follow up once a report has been submitted.
In response to your third question, it may be useful to know that it is not an obligatory requirement to submit a post-mortem when submitting a Yellow Card report with a fatal outcome. In order to identify how many Yellow Card reports associated with a COVID-19 vaccine and a fatal outcome had a post-mortem available, assessors at the MHRA would be required to manually review each case to determine if a post-mortem was performed and provided based on the supplied information. Therefore, this information is exempt from release under Section 12 of the FOI Act. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
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 of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division