NATIONAL HEALTH SERVICE, ENGLAND AND WALES Citation and commencement 1 These Regulations may be cited as the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000 and shall come into force on 14th February 2000. Interpretation 2 1 In these Regulations— “branded health service medicine” means a health service medicine which— is identifiable by and traded under a specific name given to it by the manufacturer, supplier or holder of a marketing authorisation relating to it; and is a medicinal product in respect of which a marketing authorisation has been granted; “initial price” in relation to a presentation of a medicine means— the price of that presentation which was published on the internet at www.doh.gov.uk/pprsjuly.htm on 20th January 2000 by the Department of Health , or if no price has been so published but the price is so published of another presentation which is only distinguished by— type of packaging, that published price; or pack size, the price calculated in direct proportion to that published price; “maximum price” means the price under regulation 3 or, as the case may be, 4; “marketing authorisation” means a marketing authorisation for a medicinal product for human use granted— by the competent authorities of the United Kingdom in accordance with Council Directive 65/65/ EEC of 26th January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products ; or by the European Agency for the Evaluation of Medicinal Products in accordance with Council Regulation (EEC) No. 2309/93 of 22nd July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products ; “presentation” means a particular form of a medicine which may be distinguished from other forms of that medicine by reference to its active ingredients and excipients, pack size, type of packaging, clinical indications or indicated method of administration for use in clinical practice; “supply” means supply by way of sale. 2 A health service medicine is supplied on the date on which a contract for its sale is concluded. 3 Any reference in these Regulations to a numbered regulation is a reference to a regulation which bears that number in these Regulations and any reference to a numbered paragraph in a regulation is a reference to the paragraph in that regulation which bears that number, unless the context otherwise requires. Control of prices 3 Subject to regulation 4, the maximum price which may be charged for the supply for health service purposes of a branded health service medicine of a particular presentation shall not exceed— a 95.5 per cent of the initial price where, in aggregate, the supplies of branded health service medicines made by a manufacturer or supplier to the health service in the year ending 30th September 1999 exceeded £1,000,000, determined by reference to the amounts reimbursed by the Prescription Pricing Authority in respect of that year; and b in any other case, the initial price of that presentation. Increases 4 1 The Secretary of State may— a on his own motion; or b on application made in accordance with paragraph (2); increase the maximum price by direction to a specific manufacturer or supplier. 2 An application by a specific manufacturer or supplier to the Secretary of State for an increase of that maximum price shall be made in writing and shall— a specify the health service medicine in respect of which the application is made, b state the reasons for the application, and be accompanied by the information specified in Schedule 1 to these Regulations. 3 On an application under this regulation, the Secretary of State shall, subject to paragraphs (4) and (5), reply to the manufacturer or supplier within 90 days of his receipt of that application or, if the Secretary of State gives notice to the manufacturer or supplier that the information is inadequate, within 90 days of the Secretary of State’s receipt of such additional information as the Secretary of State may in the notice require. 4 Where the number of applications received by the Secretary of State make it impracticable for him to reply to all or any of the applications within the 90 day period, he shall so notify the applicant before the end of that period. 5 In a case where the Secretary of State has given notice under paragraph (4), he shall make a decision not later than 60 days after the expiry of the 90 day period, or if he has required additional information under paragraph (3), not later than 150 days after the receipt of such additional information. Application of Regulations 5 These Regulations shall not apply— a at any time to a manufacturer or supplier to whom at the time a voluntary scheme applies; b to a supply of any medicine which is listed in Schedule 10 to the National Health Service (General Medical Services) Regulations 1992 . Information 6 1 Any manufacturer or supplier who supplies branded health service medicines shall— a keep for a minimum period of 3 years from the date of the sale of a branded health service medicine a record of the sales of each presentation of it, including— i information on the number of units of each presentation which are sold for health service purposes, and ii the income derived from sales of that presentation; for each period of 3 months beginning on 14th February 2000; b retain for a minimum period of 3 years from the date of the sale of a branded health service medicine any information which is in his possession of the kind mentioned above in respect of the period of 3 months starting on 14th February 1999 and each subsequent period of 3 months in that year; and c comply within 14 days, or such longer period as the Secretary of State may allow, with any direction made by the Secretary of State which requires the provision to him of information from that record. 2 If the Secretary of State is of the opinion that in order to implement these Regulations more information is required than that required under paragraph (1), he may direct the manufacturer or supplier in question to supply that additional information within 14 days or such longer period as he may allow. 3 Where the Secretary of State directs the supply of additional information under paragraph (2), he shall at the time of giving that direction also give written notice to the manufacturer or supplier (as the case may be) of the reason why the additional information is required. Enforcement 7 1 Any person who supplies a branded health service medicine for health service purposes at a price in excess of that permitted under these Regulations shall be liable, on the demand of the Secretary of State, to pay to him a recoverable sum calculated under Schedule 2 to these Regulations. 2 A demand made under paragraph (1) shall be made by a notice in writing addressed to the manufacturer or supplier in question and it shall state the amount of the recoverable sum calculated up to the date of the demand and the period within which it shall be paid. 3 The recoverable sum, or any part of it, which has not been paid to the Secretary of State within the period specified in the demand shall carry interest at 2.5 per cent above the rate announced from time to time by the Monetary Policy Committee of the Bank of England and for the time being in force as the official dealing rate, being the rate at which that Bank is willing to enter into transactions for providing short term liquidity in the money markets. 4 Where for a continuous period a product is sold at a price in excess of the maximum price, a contravention occurs— a on the date on which that period begins; and b on the completion of every second month during that period. Penalties 8 1 A manufacturer or supplier who fails to comply with a direction made under regulation 6(1)(c) or (2) shall, on the demand of the Secretary of State, pay to him a penalty calculated under Schedule 3 to these Regulations. 2 A demand made under paragraph (1) shall be made by a notice in writing addressed to the manufacturer or supplier in question and it shall state the amount of the penalty calculated up to the date of the demand and the period within which it shall be paid. Appeals 9 A manufacturer or supplier of branded health service medicines shall have a right of appeal in accordance with regulations made under section 37(5) of the Health Act 1999 against any decision made under these Regulations which relates to him. Alan Milburn One of Her Majesty’s Principal Secretaries of State 24th January 2000