FOI release

Freedom of Information request on funding from the Bill and Melinda Gates Foundation (FOI 21-458)

Published 28 June 2021

6th May 2021 FOI 21/458 Dear

Thank you for your email.

We do receive funding from the Bill and Melinda Gates Foundation as well as other sources outside government such as WHO. This funding mainly supports work to strengthen regulatory systems in other countries.

The majority of our income comes from the pharmaceutical industry through fees. For example, all Marketing Authorisation applicants have to pay a fee. The licensing of medicines is an independent, scientific process which is overseen by the Commission on Human Medicines (CHM).

The CHM is an independent body which advises on applications for marketing authorisations. This includes considering further representation against our provisional advice in respect of national applications; advises on the need for, and content of, risk management plans for new medicines; advises on the impact of new safety issues on the balance of risks and benefits of licensed medicines – e.g. adding warnings, restricting or suspending use of a medicine and advises the licensing authority on changes to legal status of marketing authorisations.

Please see the links below for further information. https://www.gov.uk/government/news/mhra-awarded-over-980000-for-collaboration-with-the-bill-and-melinda-gates-foundation-and-the-world-health-organisation

The current level of grant funding received from the Gates Foundation amounts to approximately $3m. This covers a number of projects and the funding is spread across 3-4 financial years. We are an executive agency of the Department of Health and Social Care. Our Annual report (link below) contains information on page 9 regarding our funding. If you require more details about the level of Government Funding please refer to the financial statements in the Annual report.

(https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/902328/MHRA_Annual_Report_and_Accounts_2020.pdf)

No COVID-19 vaccine would be approved until it has demonstrated safety, quality and efficacy through a robust clinical trial programme, as determined by the MHRA, and unless the evidence supports its use.

If you have a query about the information provided, please reply to this email.

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

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