FOI release

Freedom of information request on funding (FOI 22/702)

Published 22 March 2023

FOI 22/702

26 May 2022

Dear

Thank you for your email.

The MHRA does not receive financial contributions or donations.

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 below table for the total income received from licensing authorisations and periodic fees for the companies listed in your request. This is reflective for calendar years.

Company Name 2017 2018 2019 2020 2021 Grand Total
AstraZeneca 167,215 692,719 937,130 930,638 1,410,534 4,138,236
GlaxoSmithKline 1,822,258 2,870,167 2,651,436 1,981,793 1,544,906 10,870,560
Johnson & Johnson 5,784 23,886 14,947 20,130 9,613 74,360
Moderna 0 4,487 7,499 332 362,570 374,888
Pfizer 81,376 1,047,748 1,144,502 898,742 1,476,902 4,649,270
Grand Total 2,076,632 4,639,007 4,755,514 3,831,635 4,804,525 20,107,313

The MHRA has received funding from the Gates Foundation in relation to a number of initiatives across the Agency. The current level of grant funding received from the Gates Foundation amounts to approximately $3m and spans across several financial years. Please see the below link for further information.

MHRA awarded over £980,000 for collaboration with the Bill and Melinda Gates Foundation and the World Health Organisation - GOV.UK (www.gov.uk)

We are an executive agency of the Department of Health and Social Care. Our Annual reports (links below) contain information regarding our funding. If you require more details about the level of Government Funding please refer to the financial statements in the Annual report.

MHRA_Annual_Report_and_Accounts_2020.pdf (publishing.service.gov.uk)

MHRA_Annual_Report_and_Accounts_2020-21.pdf (publishing.service.gov.uk)

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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: [email protected]

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 Experience Centre