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.
Regulation 3(2) makes provision to replace the payment percentages in the table in regulation 3(1) of the Statutory Scheme Regulations with new payment percentages of net sales income to be payable from the 1st July 2025 for each applicable period.
Regulation 3(3) inserts new paragraphs (1AB) and (1AC) into regulation 3 of the Statutory Scheme Regulations. These new provisions mean that a manufacturer or supplier who was required to make a payment on a supply of a medicine under regulation 3(1) at 15.5%, with respect to the period beginning with 1st January 2025 and ending at the end of 30th June 2025, will be subject to a newer presentation payment percentage of 31.3% on their supplies for the period beginning 1st July 2025 to the end of 2025. This is instead of the 23.4% as stated in the table in regulation 3(1), which would otherwise apply.
Regulation 4 makes consequential amendments to regulation 4 of the Statutory Scheme Regulations.
Regulation 5 inserts new paragraph (1C) and a new defined term into paragraph (2) of regulation 23 of the Statutory Scheme Regulations that alter the auditing arrangements for presentation reports. These changes allow manufacturers and suppliers to carry out an alternate assurance procedure, known as an agreed upon procedure, of their presentation reports in place of a full audit.
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.