The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024

Amendments to Schedule 1

14.—(1) Schedule 1 (general provisions for payment scheme) is amended as follows.

(2) In paragraph 1 (payment scheme requirement)—

(a) for “regulation 3” substitute “regulation 3(1)”; and

(b) for “paragraphs 3 to 7” substitute “paragraphs 3 to 9”.

(3) After paragraph 1, insert—

“1A.   Any payment required to be made under regulation 3(1AA) by a manufacturer or supplier to whom this Schedule applies must—

(a) be paid annually at the same time as the relevant presentation report is due;

(b) be paid by electronic transfer no later than the last day of the period within which the payment must be made; and

(c) be calculated, where relevant, in accordance with the rules in paragraphs 3 to 9.”.

(4) In paragraph 2 (information requirements)—

(a) in sub-paragraph (b), for “paragraphs 3 to 7” substitute “paragraphs 3 to 9”;

(b) in table 2, in the third row—

(i) in the first column, for “financial” substitute “calendar”, and

(ii) in the third column, for “2 months” substitute “3 months” and for “financial” substitute “calendar”.

(5) In paragraphs 4 and 5 (which relate to calculations of payments and provisions of reports), after “regulation 3(1) or” in each place where it occurs (six times) insert “(1AA) or”.

(6) After paragraph 7, insert—

“8.   A manufacturer or supplier whose financial year does not end on 31st December must, in addition to the reports required to be provided in table 1, provide two or more audited sales reports or presentation reports to cover the period of 1st January to the last day of the relevant accounting reference period and from the first day of the subsequent accounting reference period to the end of 31st December of that calendar year so that, when taken together, the separate reports cover the entire calendar year.

9.   A manufacturer or supplier must provide two or more separate sales reports, audited sales reports or presentation reports for the period the applicable report covers in which a change to the payment percentages under regulation 3 or 3A occurs so that information concerning supplies of presentations made before and after that change are contained in separate reports and, when taken together, those reports cover the entire calendar quarter, financial year and, where paragraph 8 applies, the calendar year, as applicable.”.