FOI release

Freedom of Information request for the number of times Ethigen have been reported/investigated by MHRA (FOI-21-133)

Published 28 April 2021

Thank you for your communication to the MHRA in relation to a Freedom of Information request for the number of times Ethigen have been reported/investigated by MHRA for the Period 1st January 2017 - 31st December 2020 please.

We would like to inform you that we are unable to provide you with the requested information as it is exempted under Section 30:

• Section 30 –(1) Information held by a public authority is exempt information if it has at any time been held by the authority for the purpose of - (a) any investigation which the public authority has a duty to conduct with a view to it being ascertained - (i) whether a person should be charged with an offence, or (ii) whether a person charged with an offence is guilty of it, (b) any investigation which is conducted by the authority and in the circumstances may lead to a decision by the authority to institute criminal proceedings which the authority has power to conduct, or (c) any criminal proceedings which the authority has power to conduct. Section 30 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information.

We have considered the balance of the public interest when applying this exemption. The exemption is to safeguard the commercially sensitive information / industrial secrets of a third party / commercial enterprise (which can include a Government Department). This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. In this case I have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity) .

If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@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

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.

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 Service Centre