Freedom of Information request on Investigator Brochure (“IB”) owned by the MHRA (FOI 21/970)
Published 25 February 2022
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21st September 2021
FOI 21/970
Dear
Regarding your request dated 22 August 2021, the Investigator Brochures are exempt under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of these documents to be an actionable breach of confidence. Section 43 is a conditional exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the harm in releasing any documents that can be used by competitors for their commercial advantage.
Please note, for clarification, Investigator Brochures are not “owned” by MHRA, ownership of these documents is with the individual pharmaceutical companies. Further, these documents are not submitted to MHRA with the submission of a marketing authorisation application (MAA).
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 would 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.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU