FOI release

Freedom of Information request on the summaries of Yellow Card reporting (FOI 22/745)

Published 21 December 2023

FOI 22/745

7th July 2022

Dear,

Thank you for your information request, dated 8 June 2022, where you request copies of two documents ‘S&S Final Clean:’ and ‘Tracked Changes Version 1’ and “a copy of the monthly copy of the equivalent of this June Raine letter from June 2021 to March 2022”

In response to this request [FOI 22/521], you replied with a letter, FOI 22 521 Coronavirus Vaccine summary of Yellow Card reporting DLP 20.04.22022 for publicaiton 28.04.2022.pdf (whatdotheyknow.com)

In this there are two links - S&S Final Clean: and Tracked Changes Version 1. Please send me a copy of those documents 2. Please send me a copy of the monthly copy of the equivalent of this June Raine letter from June 2021 to March 2022.

3.  If any redactions are made please detail the reason for redactions as required under the FOI act and please detail it for the April letter already sent.

1. Please could you detail any conflicts of interest that June Raine may have in her role.

As requested, we are able to provide you with both documents requested, ‘S&S Final Clean:’ and ‘Tracked Changes Version 1’. These have been attached via email and embedded into this response.

Redactions have been applied to information we cannot release such as person-identifiable information (e.g. names of those below Senior Civil Servant, email addresses, telephone numbers, or the company names).

We consider that the second aspect of your request, “a copy of the monthly copy of the equivalent of this June Raine letter from June 2021 to March 2022” is unclear and we therefore request further clarification in accordance with Section 1(3) of the Act. This will allow us to then review and appropriately respond.

Regarding Conflicts of Interest, the Agency has a Conflicts of Interest policy which makes clear that Agency staff are not permitted to hold any interests in the industries the Agency regulates. All staff are required to reconfirm their declared interests annually, in addition to declaring any changes in-year as they arise. Board members’ declarations are published on the Agency’s website: Our governance - Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk).  In the latest publication, Dr Raine declared that she held an unpaid role as a member of the World Health Organisation (WHO) Committee on Safety of Medicinal Products.

The Freedom of Information Act only entitles you to 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 Reproduce or re-use MHRA information - GOV.UK (www.gov.uk).  

If you have a query about the information provided, please reply to this email.

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 you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely,

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000