FOI release

Freedom of Information request on the trial of ivermectin and the approval of the clinical trial in healthy volunteers (FOI 21/470)

Published 28 June 2021

27th May 2021 FOI 21/470 Dear

Thank you for your Freedom of Information (FOI) request pertaining to the trial of ivermectin and the approval of the clinical trial in healthy volunteers with specific dates.

Medincell submitted the following clinical trial application - EudraCT: 2020-002975-36; A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase I Trial Assessing the Pharmacokinetic Profile, Safety and Tolerability of a Continuous Daily Dosing Regimen of Ivermectin in Healthy Volunteers- Protocol number: mdc-TTG-CT-001 - for assessment to the MHRA Clinical Trials Unit on the 3rd September 2020.

The trial was approved by the MHRA on the 18th September 2020 following a review of all the accompanying evidence provided as part of the submission package.

In relation to your request for the accompanying evidence for the trial application, the MHRA is unable to provide documents such as the Investigator’s Brochure and the protocol since this study supports the development of a new product and the documents contain confidential information for which MedinCell own intellectual property rights.

Such information is exempt from disclosure under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. However MedinCell would be willing to be in direct contact with yourself to assist you further with your enquiry. Joel Richard, Chief Development Officer at MedinCell can be contacted via the following email; joel.richard@medincell.com

Where we have applied Section 41, it should be noted this is an absolute exemption and no consideration of the balance of public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. Where we have applied Section 43, it should be noted this 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 and safety profile of these vaccines.

For any medicine to be marketed in the UK, the product needs a marketing authorisation and the applicant must submit a marketing authorisation application that includes clear evidence for positive benefit-risk in respect of safety, efficacy and quality. In the UK, ivermectin is not licenced for the treatment of COVID-19, as thus far, robust evidence of its efficacy or safety have not been made available for evaluation by MHRA or its expert advisory groups.

We now consider this request closed.

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 .

Please remember to quote the reference number above in any future communications. Please note, 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.

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