The Branded Health Service Medicines (Costs) Regulations 2018

Changes over time for: Section 3

Version Superseded: 01/01/2024

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Point in time view as at 01/04/2023. This version of this provision has been superseded.

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Payment schemeU.K.

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3.—(1) Subject to [F1paragraphs (1B), (4) and (5A)], the manufacturer or supplier that is responsible for the first relevant supply of an item of presentation must pay [F2for the applicable period specified in the first column of the table below, the payment percentage specified in the corresponding entry in the second column of that table] of the net sales income received in respect of that supply to the Secretary of State in accordance with Schedule 1.

[F3Table

Applicable Period	Payment Percentage
1st April 2023 to the end of 2023	27.5%
2024 and any subsequent calendar year	27.5%]

[F4(1A) Where, in respect of an applicable period, as a consequence of an amendment to these Regulations, there is an amendment (in any manner) of a payment percentage specified in the second column of the table, the applicable payment percentage for payments payable under paragraph (1) in respect of supplies of an item of presentation under any contract entered into on or after 1st January 2019, including—

(a)a contract with a contracting authority based on a framework agreement where that framework agreement was entered into following a tender which closed on or after 1stJanuary 2019; or

(b)a public contract entered into following a tender which closed on or after 1st January 2019,

is, for that applicable period, the amended percentage.]

[F5(1B) Where paragraph (1C) applies, the payment percentage referred to in paragraph (1) for the period beginning on [F61st April 2023 to the end of 2023] is [F728.6%] and not [F827.5%].

(1C) This paragraph applies in the case of all the payments payable under paragraph (1) by a manufacturer or supplier, in respect of supplies during the period beginning on [F91st April 2023 to the end of 2023] if, in respect of any supply of an item of presentation of that manufacturer or supplier—

(a)a payment was payable under paragraph (1) in respect of that supply during the period beginning on [F101st January 2023] and ending at the end of [F1131st March 2023]; and

(b)the applicable payment percentage was [F1224.4%].]

(2) Subject to paragraph (3), for these purposes the first relevant supply is the first occasion on which that item of presentation is supplied by any manufacturer or supplier having a place of business in the United Kingdom (MS1) to another person having a place of business in the United Kingdom (MS2) that is not in the same group as MS1.

(3) If MS2 is—

(a)the marketing authorisation holder (MAH) in respect of that item of presentation; or

(b)a manufacturer or supplier in the same group as MAH,

the first relevant supply is the next supply of that item of presentation to a person having a place of business in the United Kingdom that is not in the same group as MS2.

(4) Subject to paragraph (5), paragraph (1) does not apply to the net sales income received in respect of the supply of—

(a)any item of presentation which was in respect of that supply, supplied under—

(i)a contract with a contracting authority based on a framework agreement where that framework agreement was entered into on or before the date of the coming into force of these Regulations or was entered into following a tender which closed on or before the date of the coming into force of these Regulations,

(ii)a public contract entered into on or before the date of the coming into force of these Regulations or was entered into following a tender which closed on or before the date of the coming into force of these Regulations;

(b)any item of low cost presentation;

(c)any item of parallel distributed presentation;

(d)any item of voluntary scheme presentation.

(5) Paragraph (4)(a) does not apply to any item of presentation added to a framework agreement or public contract after the coming into force of these Regulations.

[F13(5A) Where paragraph (5B) applies, the payment percentage referred to in paragraph (1) for the applicable period is 7.80% and not the percentage specified in the corresponding entry for that applicable period in the second column of the table.

(5B) Subject to paragraph (5C), this paragraph applies in respect of payments payable under paragraph (1) in respect of supplies of an item of presentation under—

(a)a contract with a contracting authority based on a framework agreement where that framework agreement was entered into on or after 1st April 2018 but before 1st January 2019, or was entered into following a tender which closed on or after 1st April 2018 but before 1st January 2019;

(b)a public contract entered into on or after 1st April 2018 but before 1st January 2019 or was entered into following a tender which closed on or after 1st April 2018 but on or before 1st January 2019.

(5C) Paragraph (5B) does not apply to payments payable in respect of supplies of any item of presentation added to a framework agreement or public contract that falls within paragraph (5B)(a) or (b) where that item is added on or after 1st January 2019.]

(6) This regulation does not apply to a small manufacturer or supplier.

Textual Amendments

F1Words in reg. 3(1) substituted (1.4.2020) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2020 (S.I. 2020/258), regs. 1, 2(2)(a)(i)

F2Words in reg. 3(1) substituted (1.1.2019) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2018 (S.I. 2018/1255), regs. 1, 2(3)(a)(ii)

F3Reg. 3(1) table substituted (1.4.2023) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2023 (S.I. 2023/239), regs. 1(1), 2(2)

F4Reg. 3(1A) inserted (1.1.2019) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2018 (S.I. 2018/1255), regs. 1, 2(3)(c)

F5Reg. 3(1B)(1C) inserted (1.4.2020) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2020 (S.I. 2020/258), regs. 1, 2(2)(b)

F6Words in reg. 3(1B) substituted (1.4.2023) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2023 (S.I. 2023/239), regs. 1(1), 2(3)(a)

F7Word in reg. 3(1B) substituted (1.4.2023) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2023 (S.I. 2023/239), regs. 1(1), 2(3)(b)

F8Word in reg. 3(1B) substituted (1.4.2023) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2023 (S.I. 2023/239), regs. 1(1), 2(3)(c)

F9Words in reg. 3(1C) substituted (1.4.2023) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2023 (S.I. 2023/239), regs. 1(1), 2(4)(a)

F10Words in reg. 3(1C)(a) substituted (1.4.2023) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2023 (S.I. 2023/239), regs. 1(1), 2(4)(b)(i)