FOI release

Freedom of Information request (FOI 22/1020)

Published 17 January 2024

3rd November 2022

FOI 22/1020

Dear

Thank you for your email of 6th October 2022 requesting information under the Freedom of Information Act 2000 relating to the disclosure of data held as follows:

‘Lists of batch numbers of Factor IX during the period 1974 – 1988. For context you referred to a previous request FOI 18/315 with details of Factor VIII batch numbers and would like the same for Factor IX.’

I can confirm under Section 1(1)(a) of the FOI Act, that the Medicines and Healthcare Products Regulatory Agency (the Agency) does hold information as requested. In addition, on this more recent search, some further log books have been discovered. The newly discovered information includes batch numbers of Factor IX material logged for testing from 1977 to 1988 and also includes batch numbers of Factor VIII material that would not have been provided to you in your previous FOI request.

We can only apologise that this information was not discovered at that time. The records dating from that time consist of old log books used by staff that have left the organisation many years ago and the books were not known of or found during the first search of information for the Infected Blood Inquiry. Recent retirement of staff has resulted in a further review of past records and these new books were discovered in an office that was to be finally vacated. This new discovery will also be reported to the Infected Blood Inquiry lawyers.

Documents being provided in this response consist of the following:

Attachments 1 – 14 – Copies of blood products sample books dating from 1977 – 1988 covering Factor IX as well as other blood products including Factor VIII. Samples and Protocols Logging Book entitled Blood Products from 14th October 1980. Copies of pages for Factor IX.

Attachment 15 – Human FIX Fraction (PL 0134/0009) plus Factor IX (PL 3473/0008) 1980-86 Section from file entitled Samples and Protocols for Blood Products Laboratory, Elstree (from 1st October 1986) and Scottish National Blood Transfusion Service, Edinburgh, (From 1 January 1987)

Attachment 16 – BPL Factor IX – 1986-98

Attachment 17 – SNBTS Factors 11-VII-IX-X – 1987-2002

Attachment 18 – OLD_Haematology_Archive_Database.final_version

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

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

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU