Statutory Instruments
2025 No. 667
NATIONAL HEALTH SERVICE, ENGLAND AND WALES
NATIONAL HEALTH SERVICE, SCOTLAND
HEALTH AND PERSONAL SOCIAL SERVICES, NORTHERN IRELAND
The Branded Health Service Medicines (Costs) (Amendment) Regulations 2025
Made
9th June 2025
Laid before Parliament
10th June 2025
Coming into force
1st July 2025
The Secretary of State for Health and Social Care makes these Regulations in exercise of the powers conferred by sections 263(1)(b) and (c), (2) and (5), 264(1) and (3), 264A(2), (4) and (7), 266(1) and 272(7)(a) and (b) and (8) of the National Health Service Act 2006(1) having had regard to the matters specified in section 266(3), (4) and (4A) of that Act.
The Secretary of State has consulted in accordance with sections 263(1) and (1A), 264(1) and 264C(1) of that Act.
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) Regulation 2018
2. The Branded Health Service Medicines (Costs) Regulations 2018(2) 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 of 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(3); 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
2006 c. 41. Section 263 was amended by the Health Service Medical Supplies (Costs) Act 2017 (c. 23) (“the 2017 Act”), sections 5 and 10(5). Section 264 was amended by the 2017 Act, section 10(6). Sections 264A and 264C were added by the 2017 Act, section 8. Section 266 was amended by the 2017 Act, sections 6(5) to (9) and 7(6). See section 275(1) of the National Health Service Act 2006 for definition of “regulations” that is relevant to the powers being exercised.
S.I. 2018/345. Relevant amending instruments are S.I. 2018/1255, 2020/258, 2022/593, 2023/239, 2023/1307 and 2024/1277.
Registered Number 02486368. Information and standards can be obtained from the Financial Reporting Council Limited, 13th Floor 1 Harbour Exchange Square, London, E13 9GE or the website https://www.frc.org.uk .