FOI release

Freedom of Information request (FOI 22/1050)

Published 17 January 2024

4th November 2022

FOI 22/1050

Dear

Thank you for your email of 21 October 2022 requesting under the Freedom of Information Act (FOIA):

“Electronic copies of the CTA submission package (including study protocol, investigator brochure and other relevant study documents) received by the MHRA in relation to the Phase I study VIR-3434-1002 ClinicalTrials.gov NCT04423393. All appropriately redacted to remove any personal or data protection material.

I understand from the ClinicalTrial.gov posting that the study is currently running in the UK with active study sites in Birmingham, London and Manchester“

I am pleased to provide you with some of the information requested, attached to this email.

These documents are provided with any personal information redacted as well as any information considered commercially sensitive, under section 40, 41 and 43 of the Freedom of Information Act.

Other application documentation has not been provided as the information was provided to us in confidence, with the expectation that it will not be released, and is therefore exempt from disclosure under Section 41 of the Freedom of Information Act. Disclosure would also likely prejudice commercial interests and therefore exemption under Section 43 also applies.

Section 41 is an absolute exemption and no consideration of the balance of public interest is required. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any overriding argument for releasing the information that outweighs the commercial harm by providing potential competitors with an insight into the product development.

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

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: [email protected]

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 Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000