FOI release

Freedom of Information request about any applications for akkermansia and ruminococcaceae (FOI-21-513)

Published 28 June 2021

Regarding your request, dated 13 May 2021, thank you for the information provided. Regarding whether MHRA has received any applications for akkermansia and ruminococcaceae, MHRA neither confirms nor denies that it holds information falling within the description specified in your request. The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act. This should not be taken as an indication that the information you requested is or is not held by the department.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

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 public interest argument that outweighs the commercial harm in alerting competitors to whether a rival product is trying to come onto the market or not. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Regarding your enquiry concerning the current development of these products and their possible use in the NHS, in our role as the medicines regulator, MHRA is not in a position to hold product licences itself or to solicit for new product licence applications (or the adaptation of current product licences for new indications). Once an application is made, then supporting data will be assessed with regard to its quality, safety and efficacy for the conditions it is intended to treat, and to confirm that it has an acceptable balance of risk and benefit. Applications for new product licences or to amend current product licences would need to be submitted by marketing authorisation holders themselves to MHRA.

Timelines for the different product licence application routes are within the guidance documents which are available at New guidance and information for industry from the MHRA - GOV.UK (www.gov.uk)

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: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000