The Branded Health Service Medicines (Costs) Regulations 2018

New presentation

9.—(1) A manufacturer or supplier intending to place on the market a new presentation must record and keep for a period of 6 years information required under this regulation.

(2) At least 60 days prior to the proposed date on which a manufacturer or supplier is intending to place on the market a new presentation, the manufacturer or supplier must notify the Secretary of State of its intention to do so.

(3) A notification under paragraph (2) by a manufacturer or supplier to the Secretary of State must be made in writing and must—

(a) specify the presentation in respect of which the notification is made;

(b) include the summary of product characteristics;

(c) specify the proposed date for placing on the market the new presentation;

(d) specify the proposed maximum price; and

(e) include any relevant information relating to the factors set out under paragraphs (8)(a) to (g).

(4) Within 28 days of receiving a notification in accordance with paragraph (3), the Secretary of State must give the manufacturer or supplier an information notice specifying the information required in relation to any of the relevant factors set out under paragraphs (8)(h) and (i).

(5) Unless further information relating to the factors listed at paragraph (8) is requested, the Secretary of State must specify the maximum price at which that new presentation may be supplied by direction to the manufacturer or supplier within a period of 28 days of receiving the information under paragraph (4).

(6) Where further information relating to the factors listed at paragraph (8) is required, the Secretary of State must within 28 days of receiving the information under paragraph (4), notify and where appropriate, by giving an information notice, the manufacturer or supplier that further information is required, and inform the manufacturer or supplier of the maximum price within 28 days of receiving that further information.

(7) Where a manufacturer or supplier fails to notify the Secretary of State of its intention to place the presentation on the market within the 60 day period referred to in paragraph (2) or provide the Secretary of State with the information that the Secretary of State requires to determine the maximum price, the Secretary of State may, by direction, specify the maximum price of that presentation.

(8) The maximum price for an item of a new presentation to which this regulation applies may be determined by the Secretary of State, having regard to, among other factors, the following factors—

(a) the clinical need for the new presentation at the time that the notification under paragraph (2) is made and during the period that the notification is being considered by the Secretary of State;

(b) the price and associated operational costs of therapeutically equivalent or comparable medicines to that new presentation at the time that the notification under paragraph (2) is made and during the period that the notification is being considered by the Secretary of State;

(c) the price and associated operational costs of the new presentation in the European Economic Area and any other markets if it is available elsewhere in the world at the time that notification under paragraph (2) is made and during the period that the notification is being considered by the Secretary of State;

(d) whether the presentation contains a new active substance;

(e) the date on which the patent protection period for each indication of the new presentation expires;

(f) the total profit of the manufacturer or supplier before interest charges and taxes for their previous accounting reference period as set out in the manufacturer’s or supplier’s individual accounts;

(g) the estimated total quantity to be supplied and estimated total net sales income of the new presentation over the period of the first five financial years of the manufacturer’s or supplier’s sales of the new presentation, or where the patent protection period expires before the end of the first five financial years, the period until the date of the expiration of the patent protection period;

(h) the reasonableness of the estimated costs of the presentation over the period of the first five financial years of the manufacturer’s or supplier’s sales of the new presentation, or where the patent protection period expires before the end of the first five financial years, the period until the date of the expiration of the patent protection period, including—

(i) manufacturing and supply costs,

(ii) research and development costs,

(iii) operational costs, and

(iv) any other costs;

(i) the price at which the manufacturer’s or supplier’s reasonable costs for that presentation, as determined by the Secretary of State would be met.

(9) For the purposes of this regulation, where there is more than one patent protection period, the patent protection period which expires on the latest date will apply.

(10) For the purposes of paragraph (8)(d) a presentation will only be considered to contain a “new active substance”, where—

(a) the European Public Assessment Report published by the European Medicines Agency(1) in relation to the presentation in accordance with Article 13.3 of the Regulation (EC) 726/2004 of the European Parliament and of the Council of 31st March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency confirms that the presentation contains a new active substance; or

(b) the Assessment Report published by the licensing authority in relation to the presentation in accordance with Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community code relating to medicinal products for human use(2) confirms that the presentation contains a new active substance.

(11) In these Regulations “new presentation” means a presentation which at the time the notification under paragraph (3) must be made, is not subject to a maximum price under regulation 8(2) or under a direction made under regulation 8(3), 10(1), 11(2), 12(2), or 13(1).

(12) In this regulation—

“licensing authority” is to be construed in accordance with regulation 6 of the 2012 Regulations; and

“summary of product characteristics” is to be construed in accordance with regulation 8(1) of the 2012 Regulations.

(1)

As established under Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ No L 136, 30.04.2004, p 1).

(2)

OJ No L 311, 28.11.2001, p.67; article 21 was amended by Directive 2011/62/EU of the European Parliament and of the Council of 15 December 2010 (OJ No. L 348 31.12.2010, p 74).