# The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024, Note: 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 amendments update the payment percentages and introduce a new approach for calculating the amount of the net sales income manufacturers and suppliers subject to the Statutory Scheme Regulations will pay to the Secretary of State based on whether the supplies of the presentations are of newer presentations or older presentations.
Regulation 3 makes provision to amend regulation 1(2) of the Statutory Scheme Regulations to introduce new defined terms relevant to the amendments made by these Regulations.
Regulation 4(2) makes provision to replace the payment percentages in regulation 3(1) of the Statutory Scheme Regulations with new payment percentages for net sales income of newer presentations and older presentations payable by manufacturers and suppliers subject to the Statutory Scheme Regulations from the 1st January 2025.
Regulation 4(3) inserts a new regulation 3(1AA) in the Statutory Scheme Regulations which makes provision for additional amounts to be payable on the net sales income of manufacturers and suppliers who supply older presentations.
Regulation 4(4) amend regulation 3(4) and regulation 4(5) inserts a new regulation 3(4A) into the Statutory Scheme Regulations to make provision that exempts supplies of certain presentations from the requirement to make payments under regulation 3(1) or the additional payment under new regulation 3(1AA).
Regulations 5 to 9 insert new regulations 3A to 3D in the Statutory Scheme Regulations which make provision for calculating the additional payments on older presentations, determining which are newer presentations and older presentations and for the Secretary of State to determine and issue reference prices for older presentations that are relevant to calculating the additional payments due under new regulation 3(1AA).
Regulation 9 makes consequential amendments to regulation 4 of the Statutory Scheme Regulations.
Regulations 10, 11 and 12 make amendments to the Statutory Scheme Regulations requiring manufacturers and suppliers to collect, audit and provide to the Secretary of State certain information concerning the supply of branded health service medicines in sales reports and presentation reports.
Regulation 13 amends regulation 26 of the Statutory Scheme Regulations to make provision to allow the Secretary of State to impose sanctions on a manufacturer or supplier who fails to comply with the requirements to provide relevant information.
Regulation 14 amends Schedule 1 of the Statutory Scheme Regulations to make provision for manufacturers and suppliers to make the additional payments required by new regulation 3(1AA) and associated reporting obligations.
Regulation 15 amends Schedule 2 to increase the threshold for qualification as a small manufacturer or supplier under the Statutory Scheme Regulations from £5 million to £6 million.
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.

---
Source: https://www.legislation.gov.uk/uksi/2024/1277/note (the official version)
Page: https://openlegislation.uk/branded-health-service-medicines-costs-amendment-regulations-2024/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.