The Branded Health Service Medicines (Costs) (Amendment) Regulations 2026
These Regulations, made by the Secretary of State for Health and Social Care, amend the Branded Health Service Medicines (Costs) Regulations 2018, which establishes a scheme requiring manufacturers and suppliers of branded medicines for the National Health Service (NHS) to pay amounts based on net sales income; the amendments update specific payment percentages applicable for periods beginning July 1st, 2026, and for subsequent years across England, Wales, Scotland, and Northern Ireland.
Arguments For
Ensures the continued financial sustainability of the statutory scheme designed to manage the cost of branded medicines supplied to the Health Service through updated payment percentages for manufacturers.
Adjusts payment rates prospectively from July 2026, providing clear financial planning for pharmaceutical suppliers regarding their obligations under the scheme.
Implements necessary legal updates to legislation governing medicine costs, deriving authority from the foundational National Health Service Act 2006.
Arguments Against
Changes to payment percentages may alter the financial burden on manufacturers and suppliers of branded medicines, potentially impacting R&D investment or pricing strategies.
The shifting percentages between different periods (e.g., 24.3% down to 8.7%) introduce complexity in calculating and reporting net sales income for compliance purposes.
The amendment may represent a periodic, potentially recurring, mechanism for cost containment that could be perceived as arbitrary by the pharmaceutical industry.
STATUTORY INSTRUMENTS
2026 No. 614
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 2026
Made - - - -
9th June 2026
Laid before Parliament
10th June 2026
Coming into force - -
1st July 2026
These official documents establish the 'Branded Health Service Medicines (Costs) (Amendment) Regulations 2026' as a Statutory Instrument, identified by the number 2026 No. 614.
The instrument applies to the National Health Service (NHS) policy framework spanning England and Wales, Scotland, and health and personal social services in Northern Ireland.
It received its official date of making on June 9th, 2026, was presented to Parliament on June 10th, 2026, and is scheduled to officially begin its enforcement on July 1st, 2026.
The Secretary of State for Health and Social Care makes the following Regulations in exercise of the powers conferred by sections 263(1)(b) and (c), (2) and (5), 264(3), 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) of that Act.
The Secretary of State for Health and Social Care created these Regulations using powers explicitly granted by several sections of the National Health Service Act 2006.
The Secretary of State confirms that when making these rules, consideration was given to specific criteria detailed in sections 266(3), (4), and (4A) of that Act.
Furthermore, the Secretary of State confirms that the mandatory consultation process required under sections 263(1) and (1A) of the 2006 Act was completed prior to enacting these amendments.
Citation, commencement and extent
- -(1) These Regulations may be cited as the Branded Health Service Medicines (Costs) (Amendment) Regulations 2026 and come into force on 1st July 2026.
- (2) These Regulations extend to England and Wales, Scotland and Northern Ireland.
The first substantive section names the instrument officially as the 'Branded Health Service Medicines (Costs) (Amendment) Regulations 2026.' It confirms the operative date for these changes, which is July 1st, 2026.
Additionally, the geographical reach of these Regulations is defined, stating they apply across all parts of the United Kingdom covered by the NHS system: England, Wales, Scotland, and Northern Ireland.
( 1 ) 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). 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.
This is a legislative footnote detailing the source acts and previous amendments affecting the primary legislation.
It confirms that the National Health Service Act 2006 (c. 41) is the foundational legislation being referenced.
The footnote specifies how various sections (263, 264, and 266) of the 2006 Act were previously modified by the Health Service Medical Supplies (Costs) Act 2017, providing context for the current regulatory powers being exercised.
Amendments to the Branded Health Service Medicines (Costs) Regulations 2018
- -(1) Regulation 3 (payment scheme) of the Branded Health Service Medicines (Costs) Regulations 2018( 2 ) is amended as follows.
This section outlines the core purpose of the instrument: to make specific changes to the existing 'Branded Health Service Medicines (Costs) Regulations 2018'.
Specifically, the amendments target Regulation 3 of the 2018 rules, which details the payment scheme whereby pharmaceutical suppliers contribute to NHS costs based on sales.
- (2) In paragraph (1), for the table substitute the following table-
' Table
| Applicable Period | Newer presentation payment percentage | Older presentation payment percentage | |----------------------------------------------------------------------|-----------------------------------------|-----------------------------------------| | 1st July 2026 to the end of 2026 | 16.5% | 11% | | 1st January 2027 to the end of 2027 and any subsequent calendar year | 16.5% | 10.9%'. |
This part replaces the existing cost contribution table found in Regulation 3(1) of the 2018 scheme with a new schedule of payment percentages applicable from July 1st, 2026.
For the final half of 2026 (July 1st to December 31st), the payment percentages are set at 16.5% for newer medicine presentations and 11% for older presentations.
From January 1st, 2027, onward, the rate for older presentations is adjusted slightly downward to 10.9%, while the newer presentation rate remains 16.5%.
- (a) for '1st July 2025 and ending at the end of 2025', substitute '1st July 2026 and ending at the end of 2026'; and
- (b) for '31.3% and not 23.4%', substitute '8.7% and not 16.5%'.
This modification appears to be part of an amendment to a transitional or specific clause within the payment scheme regulations, likely concerning a rebate or adjustment mechanism.
The dates are shifted forward by one calendar year, referencing the period from mid-2026 instead of mid-2025.
Concurrently, specific percentage values related to these adjustments are updated, changing from figures tied to 23.4% and 31.3% to figures involving 8.7% and 16.5%.
(4) In paragraph (1AC)-
- (a) for '1st July 2025 and ending at the end of 2025', substitute '1st July 2026 and ending at the end of 2026';
- (b) in sub-paragraph (a), for '1st January 2025 and ending at the end of 30 June 2025', substitute '1st January 2026 and ending at the end of 30 June 2026'; and
- (c) in sub-paragraph (b), for '15.5%', substitute '24.3%'.
This updates transitional provisions found within paragraph (1AC) of the original scheme regulations, again shifting the relevant timeframes forward to correspond with 2026 activities.
The temporal references for the first half and second half of the year are adjusted to cover January to June 2026, replacing the corresponding clauses for January to June 2025.
A specific percentage within sub-paragraph (b) is altered from 15.5% to 24.3%.
Signed by the authority of the Secretary of State for Health and Social Care
9th June 2026
Preet Kaur Gill Parliamentary Under-Secretary of State Department of Health and Social Care
This section confirms the formal signing of the instrument by a responsible government official.
Preet Kaur Gill, acting as Parliamentary Under-Secretary of State for the Department of Health and Social Care, signed the document on June 9th, 2026, thereby authorizing its provisions.
( 2 ) S.I. 2018/345. Relevant amending instruments are S.I. 2018/1255, 2020/258, 2022/593, 2023/239, 2023/1307, 2024/1277 and 2025/667.
This footnote identifies the primary legislation being amended, specifically Statutory Instrument S.I. 2018/345.
It also lists the series of previous Statutory Instruments that have already modified these cost regulations since their introduction in 2018.
This history of amendments shows that the medicine costs scheme is subject to regular, annual, or periodic updates by subsequent regulatory actions.
EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations amend the Branded Health Service Medicines (Costs) Regulations 2018 (S.I. 2018/345) (the 'Statutory Scheme Regulations'). The Statutory Scheme Regulations, amongst other matters, make a scheme for the purpose of requiring specific manufacturers and suppliers of branded medicines for health service use to pay certain amounts to the Secretary of State. These amounts are calculated by reference to the net sales income or estimated net sales income from supplies of such medicines. These amendments update the payment percentages for 2026 and subsequent years.
The Explanatory Note clarifies the function of the instrument, noting that it is supplementary and not legally part of the Regulations themselves.
It confirms that the prior 2018 Regulations established a formal scheme.
This scheme mandates payments from specific manufacturers and suppliers of branded medicines based on their net sales income from supplying drugs to the NHS. The current instrument's main action is updating the fixed payment percentages for the remainder of 2026 and for all future years.
Regulation 2(2) makes provision to replace the newer presentation payment percentages in the table in regulation 3(1) of the Statutory Scheme Regulations with new payment percentages applicable to net sales income to be payable from 1st July 2026 for each applicable period.
Regulation 2(2) specifically details the substitution of the payment percentage schedule within Regulation 3(1) of the 2018 rules.
This replacement establishes the exact percentages manufacturers must pay on their net sales income.
These new rates take effect immediately for the second half of 2026, defining the financial expectations for pharmaceutical suppliers moving forward.
Regulation 2(3) and (4) amend paragraphs (1AB) and (1AC) of regulation 3 of the Statutory Scheme Regulations. The amendments update the payment percentages to be paid by manufacturers or suppliers who have paid the higher rate of 24.3% on their supplies during the first half of 2026 and will pay a reduced rate of 8.7% from 1st July 2026 to 31st December 2026 to account for the higher rate they have paid on supplies during the first 6 months of 2026. The rate of 8.7% is instead of the 16.5% as stated in the table at regulation 3(1) which would otherwise apply.
Regulations 2(3) and 2(4) adjust specific clauses relating to transitional adjustments for suppliers who faced a significant initial rate in early 2026.
Manufacturers who paid a high rate (24.3% is referenced) during January to June 2026 receive a compensatory reduction for the period July 1st to December 31st, 2026, paying only 8.7% during this latter six-month period.
This mechanism effectively smooths the effective annual contribution rate by replacing the standard rate of 16.5% shown in the main table.
An impact assessment relating to this instrument has been prepared and copies can be obtained from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU and is available on the www.legislation.gov.uk website.
A formal Impact Assessment accompanied these Regulations, detailing the expected effects of the changes on stakeholders, particularly the pharmaceutical industry.
Interested parties can obtain copies of this assessment directly from the Department of Health and Social Care in London or via the official UK legislation website.
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