Explanatory note

These Regulations, which apply to the United Kingdom, amend the Branded Health Service Medicines (Costs) Regulations 2018 (the “Statutory Scheme Regulations”). The Statutory Scheme Regulations, amongst other matters, make a scheme for the purposes of requiring specific manufacturers and suppliers of medicines, for NHS use, to pay amounts to the Secretary of State. These amounts are calculated by reference to their net sales income or estimated net sales income from supplies of such medicines.

Regulation 2(2)(a)(ii) amends the applicable periods and payment percentages in the table in regulation 3(1) of the Statutory Scheme Regulations.

Regulation 2(2)(b) inserts new paragraphs (1B) and (1C) into regulation 3. These mean that a manufacturer or supplier who is required to make a payment on a supply of a medicine under regulation 3(1) at 14.7%, with respect to the period beginning with 1st January 2020 and ending at the end of 31st March 2020, will be subject to a payment percentage of 5.0% on their supplies for the period beginning 1st April 2020 to the end of 2020. This as opposed to the payment percentage of 7.4% as stated in the table in regulation 3(1).

Regulations 2(2)(a)(i) and 2(3) make consequential amendments.

A copy of the impact assessment will be published alongside this instrument on the legislation.gov.uk website.