FOI release

Freedom of Information request (FOI 22/1185)

Published 17 January 2024

FOI 22/1185

18th December 2022

Dear

Thank you for your email.

The breakdown of our income for the previous two financial years can be found in our published annual reports.

MHRA_Annual_Report_and_Accounts_2021-22.pdf (publishing.service.gov.uk)

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

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.

We are an executive agency of the Department of Health and Social Care. Our 21/22 annual report contains information on page 13 and 48 regarding our funding. If you require more details, please refer to the financial statements - page 126 onwards. Notes 3.1 and 3.2 detail the breakdowns of each source.

The below extract is taken from page 145.

Last year our activities were funded as follows:

• Medicines regulation was funded from fees charged to the regulated industry according to the full cost recovery rules set out in Her Majesty’s Treasury’s Managing Public Money
• Devices regulation was primarily funded by DHSC with approximately 10% of its revenue from fees charged for services
• NIBSC derived almost half its revenue from fees charged for services, including the sale of biological standards; NIBSC also received research funding, including DHSC research funding through the Regulatory Science Research Unit (RSRU); and DHSC provided the remaining funding to finance its important public health functions

CPRD is jointly funded by the Agency and DHSC’s National Institute for Health Research (NIHR) and managed and operated by the Agency with DHSC having equal voting rights in direction setting and decision making

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

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.

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