The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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Change 1
4 Amendments to regulation 3
(1) Regulation 3 (payment scheme) is amended as follows. (2) For paragraph (1), substitute— (1) Subject to paragraphs (1AA), (4) and (5A), the manufacturer or supplier that is responsible for the first relevant supply of an item of presentation must pay for the applicable period specified in the first column of the table below the payment percentage specified in the— (a) second column for each newer presentation; or (b) third column for each older presentation, of that table of the net sales income received in respect of that supply to the Secretary of State in accordance with Schedule 1. Table Applicable period | Newer presentation payment percentage | Older presentation payment percentage 1st January 2025 to the end of 2025 | 15.5% | 10.6% 1st January 2026 to the end of 2026 | 17.9% | 11% 1st January 2027 to the end of 2027 and any subsequent calendar year | 20.1% | 10.9%. . (3) After paragraph (1A), insert— (1AA) Subject to paragraph (4A), in addition to any sum that may be required to be paid under paragraph (1)(b), the manufacturer or supplier that is responsible for the first relevant supply of an item of presentation that is an older presentation must pay the payment percentage calculated in accordance with regulation 3A of the net sales income received in respect of that supply to the Secretary of State in accordance with Schedule 1. . (4) In paragraph (4), for “paragraph (1) does” substitute “paragraphs (1) and (1AA) do”. (5) After paragraph (4), insert— (4A) Paragraph (1AA) does not apply to the net sales income received by a manufacturer or supplier in respect of the supply of— (a) any item of presentation that is a plasma derived medicinal product; or (b) any item of presentation that is an older presentation where the cumulative net sales income from all older presentations with a common relevant virtual therapeutic moiety that the manufacturer or supplier supplies for health service use does not exceed £1,500,000 during a relevant calendar year. . (6) In paragraph (5H), after the definition “licensing authority”, insert— “plasma derived medicinal product” means a presentation that includes an active ingredient from any of the following virtual therapeutic moieties— albumin human; anti-D immunoglobulin; C1- esterase inhibitor; factor VIII plus von Willebrand factor; factor X; factor XIII; fibrinogen; high purity factor IX; human alpha1 -proteinase inhibitor; human prothrombin complex concentrate; normal immunoglobulin human; protein C human; or von Willebrand factor; .
4 Amendments to regulation 3
(1) Regulation 3 (payment scheme) is amended as follows. (2) For paragraph (1), substitute— (1) Subject to paragraphs (1AA), (4) and (5A), the manufacturer or supplier that is responsible for the first relevant supply of an item of presentation must pay for the applicable period specified in the first column of the table below the payment percentage specified in the— (a) second column for each newer presentation; or (b) third column for each older presentation, of that table of the net sales income received in respect of that supply to the Secretary of State in accordance with Schedule 1. Table Applicable period | Newer presentation payment percentage | Older presentation payment percentage 1st January 2025 to the end of 2025 | 15.5% | 10.6% 1st January 2026 to the end of 2026 | 17.9% | 11% 1st January 2027 to the end of 2027 and any subsequent calendar year | 20.1% | 10.9%. . (3) After paragraph (1A), insert— (1AA) Subject to paragraph (4A), in addition to any sum that may be required to be paid under paragraph (1)(b), the manufacturer or supplier that is responsible for the first relevant supply of an item of presentation that is an older presentation must pay the payment percentage calculated in accordance with regulation 3A of the net sales income received in respect of that supply to the Secretary of State in accordance with Schedule 1. . (4) In paragraph (4), for “paragraph (1) does” substitute “paragraphs (1) and (1AA) do”. (5) After paragraph (4), insert— (4A) Paragraph (1AA) does not apply to the net sales income received by a manufacturer or supplier in respect of the supply of— (a) any item of presentation that is a plasma derived medicinal product; or (b) any item of presentation that is an older presentation where the cumulative net sales income from all older presentations with a common relevant virtual therapeutic moiety that the manufacturer or supplier supplies for health service use does not exceed £1,500,000 during a relevant calendar year. . (6) In paragraph (5H), after the definition “licensing authority”, insert— “plasma derived medicinal product” means a presentation that includes an active ingredient from any of the following virtual therapeutic moieties— albumin human; anti-D immunoglobulin; C1- esterase inhibitor; factor VIII plus von Willebrand factor; factor X; factor XIII; fibrinogen; high purity factor IX; human alpha1 -proteinase inhibitor; human prothrombin complex concentrate; normal immunoglobulin human; protein C human; or von Willebrand factor; .
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