NATIONAL HEALTH SERVICE, ENGLAND AND WALES Citation, commencement and extent 1 1 These Regulations may be cited as the Branded Health Service Medicines (Costs) (Amendment) Regulations 2025 and come into force on 1st July 2025. 2 These Regulations extend to England and Wales, Scotland and Northern Ireland. Amendments to the Branded Health Service Medicines (Costs) Regulations 2018 2 The Branded Health Service Medicines (Costs) Regulations 2018 are amended as follows. Amendments to regulation 3 3 1 Regulation 3 (payment scheme) is amended as follows. 2 In paragraph (1)— a for “paragraphs (1AA), (4) and (5A)” substitute “paragraphs (1AA), (1AB), (4) and (5A)” ; and b for the table substitute the following table— Table Applicable Period Newer presentation payment percentage Older presentation payment percentage 1st July 2025 to the end of 2025 23.4% 10.6% 1st January 2026 to the end of 2026 24.3% 11% 1st January 2027 to the end of 2027 and any subsequent calendar year 26.0% 10.9% . 3 After paragraph (1AA) insert— 1AB Where paragraph (1AC) applies, the newer presentation payment percentage referred to in paragraph (1) for the period beginning on 1st July 2025 and ending at the end of 2025 is 31.3% and not 23.4%. 1AC This paragraph applies in the case of the payments payable under paragraph (1) by a manufacturer or supplier in respect of supplies during the period beginning on 1st July 2025 and ending at the end of 2025, if, in respect of any supply of an item of presentation that was a newer presentation of that manufacturer or supplier— a a payment was payable under paragraph (1) in respect of a supply during the period beginning on 1st January 2025 and ending at the end of 30 June 2025; and b the applicable payment percentage was 15.5%. . Amendments to regulation 4 4 In regulation 4 (direction to make a payment)— a in paragraph (2)(b) for “regulation 3(1) or (5A)” substitute “regulation 3(1), (1AA), (1AB) or (5A)” ; and b in paragraph (3)(c) for “regulation 3(1) or (5A)” substitute “regulation 3(1), (1AA), (1AB) or (5A)” . Amendment to regulation 23 5 In regulation 23 (audited information)— a after paragraph (1B) insert— 1C A manufacturer or supplier who provides a presentation report to the Secretary of State in accordance with Schedule 1 or Schedule 3 must, at the same time as providing an audited sales report, provide the Secretary of State with— a a statement from the manufacturer or supplier that the most recently submitted presentation report has been subject to procedures agreed between the manufacturer or supplier and a qualified independent auditor in accordance with an applicable related services standard; and b the relevant report of the qualified independent auditor produced in accordance with the applicable related services standard. ; and b in paragraph (2), omit “and” after the definition of “applicable auditing standards” and insert the following definition in the appropriate place— “ applicable related services standard ” means any relevant International Standard on Related Services recognised by, or equivalent standard produced by, the Financial Reporting Council Limited ; and . Signed by the authority of the Secretary of State for Health and Social Care. Karin Smyth Minister of State Department of Health and Social Care 9th June 2025