The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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Change 1
7 Insertion of new regulation 3C
After regulation 3B (meaning of newer presentation and older presentation) insert— Reference prices for older presentations 3C (1) The Secretary of State must, by direction, determine the reference price of each older presentation to the manufacturer or supplier who has supplied that item of presentation and is liable to make a payment in accordance with regulation 3(1AA). (2) Whether or not the Secretary of State has received a request under paragraph (3)— (a) the Secretary of State may, by direction, to the manufacturer or supplier who has supplied the item of presentation, change or alter a reference price if the Secretary of State considers it is reasonable to do so; and (b) the changed or altered reference price is to apply, unless stated otherwise in the direction, from the date of the relevant direction. (3) Except where a direction under paragraphs (1) or (2) has previously been given to the manufacturer or supplier, a manufacturer or supplier who may be required to make a payment under regulation 3 during a relevant period must make a request to the Secretary of State for a reference price for each older presentation— (a) where the circumstances in regulation 9(1) apply, at the same time as they are required to make a notification under regulation 9(2); or (b) in any other circumstance where the manufacturer or supplier does not have a direction specifying the reference price for a particular older presentation, within 30 days of the manufacturer or supplier becoming aware they may be liable to make a payment under regulation 3(1AA) in respect of the presentation. (4) A request made under paragraph (3) must— (a) be made in writing; (b) specify the details of the presentation in respect of which the request is made; and (c) include any relevant information relating to the factors set out in regulation 3D(5). (5) Subject to paragraph (6), the Secretary of State must, by direction, within a period of 90 days following receipt of the information to be included in a request under paragraph (3) or paragraph (7), determine the reference price of the item of presentation to the relevant manufacturer or supplier. (6) Where the number of requests received by the Secretary of State under paragraph (3) makes it impracticable for the Secretary of State to determine the reference price to a manufacturer or supplier in accordance with paragraph (5), or insufficient information has been provided, the Secretary of State may extend that period for a further 60 days and must notify the manufacturer or supplier within the 90 day period. (7) Within 28 days of receiving the information to be included in a request under paragraph (3), where further information is required in order to determine the reference price, the Secretary of State must give the manufacturer or supplier an information notice specifying the further information that is required. (8) The Secretary of State may, by giving an information notice, require a manufacturer or supplier to provide information— (a) to assist in the determination of a reference price under paragraph (1) or (2) in accordance with regulation 3D; (b) within 28 days of receiving the information under paragraph (7) where the Secretary of State considers that further information is required to determine the reference price for a presentation; or (c) where the Secretary of State considers that the average selling price, maximum price or other relevant pricing information of any relevant medicine has been altered or otherwise manipulated solely or mainly for the purpose of affecting the reference price that may be applied to an older presentation. (9) In this regulation and regulation 3D— “reference price” means the price assigned to an item of presentation in a direction given in accordance with paragraph (1), (2)(a) or (5); “relevant period” has the meaning given to it in regulation 3A(5); “relevant virtual therapeutic moiety” has the meaning given to it in regulation 3B(9). .
7 Insertion of new regulation 3C
After regulation 3B (meaning of newer presentation and older presentation) insert— Reference prices for older presentations 3C (1) The Secretary of State must, by direction, determine the reference price of each older presentation to the manufacturer or supplier who has supplied that item of presentation and is liable to make a payment in accordance with regulation 3(1AA). (2) Whether or not the Secretary of State has received a request under paragraph (3)— (a) the Secretary of State may, by direction, to the manufacturer or supplier who has supplied the item of presentation, change or alter a reference price if the Secretary of State considers it is reasonable to do so; and (b) the changed or altered reference price is to apply, unless stated otherwise in the direction, from the date of the relevant direction. (3) Except where a direction under paragraphs (1) or (2) has previously been given to the manufacturer or supplier, a manufacturer or supplier who may be required to make a payment under regulation 3 during a relevant period must make a request to the Secretary of State for a reference price for each older presentation— (a) where the circumstances in regulation 9(1) apply, at the same time as they are required to make a notification under regulation 9(2); or (b) in any other circumstance where the manufacturer or supplier does not have a direction specifying the reference price for a particular older presentation, within 30 days of the manufacturer or supplier becoming aware they may be liable to make a payment under regulation 3(1AA) in respect of the presentation. (4) A request made under paragraph (3) must— (a) be made in writing; (b) specify the details of the presentation in respect of which the request is made; and (c) include any relevant information relating to the factors set out in regulation 3D(5). (5) Subject to paragraph (6), the Secretary of State must, by direction, within a period of 90 days following receipt of the information to be included in a request under paragraph (3) or paragraph (7), determine the reference price of the item of presentation to the relevant manufacturer or supplier. (6) Where the number of requests received by the Secretary of State under paragraph (3) makes it impracticable for the Secretary of State to determine the reference price to a manufacturer or supplier in accordance with paragraph (5), or insufficient information has been provided, the Secretary of State may extend that period for a further 60 days and must notify the manufacturer or supplier within the 90 day period. (7) Within 28 days of receiving the information to be included in a request under paragraph (3), where further information is required in order to determine the reference price, the Secretary of State must give the manufacturer or supplier an information notice specifying the further information that is required. (8) The Secretary of State may, by giving an information notice, require a manufacturer or supplier to provide information— (a) to assist in the determination of a reference price under paragraph (1) or (2) in accordance with regulation 3D; (b) within 28 days of receiving the information under paragraph (7) where the Secretary of State considers that further information is required to determine the reference price for a presentation; or (c) where the Secretary of State considers that the average selling price, maximum price or other relevant pricing information of any relevant medicine has been altered or otherwise manipulated solely or mainly for the purpose of affecting the reference price that may be applied to an older presentation. (9) In this regulation and regulation 3D— “reference price” means the price assigned to an item of presentation in a direction given in accordance with paragraph (1), (2)(a) or (5); “relevant period” has the meaning given to it in regulation 3A(5); “relevant virtual therapeutic moiety” has the meaning given to it in regulation 3B(9). .
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