Freedom of Information request on the list of applications regarding Innovation Passports (FOI 22/729)
Published 27 March 2023
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-13-june-2022/freedom-of-information-request-on-the-list-of-applications-regarding-innovation-passports-foi-22729
FOI 22/729
13th June 2022
Dear
Thank you for your email.
This information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the 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 this information to be an actionable breach of confidence. Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information on products that have not yet been authorised for use and are still under development. This information can be used by competitors for their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity. Further, the release of this information would inhibit companies from submitting ILAP applications and sharing such information with MHRA, which would be commercially harmful to the industry in general.
If you have a query about this email, please do not hesitate to contact us at info@mhra.gov.uk
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
After that, if you remain dissatisfied, you may write to the Information Commissioner at;
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
MHRA Customer Experience Centre