FOI release

Freedom of Information request about the Bill and Melinda Gates Foundation (FOI-21-509)

Published 28 June 2021

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 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