FOI release

Freedom of Information request on Ivermectin for treatment of COVID-19 (FOI 21-708)

Published 13 August 2021

30th June 2021 FOI 21/708

Dear

Thank you for your email.

Ivermectin is currently not approved in the UK for the prophylaxis or treatment of COVID-19, however clinicians may prescribe unlicensed medicines if, in their clinical judgement, there is no suitable licensed available alternative that is capable of meeting their individual patient needs. This is done under their own responsibility and should take into account the safe use of medicines. Individuals / patients should discuss their particular needs with their doctors and general practitioners including whether they might benefit from entering a clinical trial of experimental medicines.

The WHO has recently issued a Guidance note advising that ivermectin is only to be used to treat COVID-19 within clinical trials. Please see link: WHO: Ivermectin should only-be-used-to-treat-covid-19-within-clinical-trials. The FDA has also recently advised that “they (FDA) have not approved ivermectin for use in treating or preventing COVID-19 in humans and that FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19. Taking a drug for an unapproved use can be very dangerous: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19- FDA. Likewise, the EMA: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials - European Medicines Agency (europa.eu)

There is currently a clinical trial with ivermectin ongoing in the UK and results are awaited. For ivermectin to be granted a marketing authorisation, an application must be submitted to the MHRA for review. A marketing authorisation for an ivermectin-containing medicine would only be issued based on robust data to show a positive risk benefit for the quality, safety and efficacy of the product.

The MHRA, together with independent advisory groups, continues to review the emerging body of evidence regarding potential medicines for the prevention or treatment of COVID-19.

Regarding your comment concerning the impartial assessment of ivermectin, the composition of our committees (including the Commission on Human Medicine (CHM) are available on our website. This information includes information concerning the committee members conflicts of interest. A link to this information is provided below: https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership

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