The Health Service Medicines (Control of Pricesof Branded Medicines) Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which apply to the United Kingdom, control the price of branded medicines sold for national health service purposes. They apply only to medicines in respect of which marketing authorisations have been granted (regulation 2) that are supplied by companies which are not scheme members within the meaning of Section 33(4) of the Health Act 1999 (see paragraph 4 below).

The maximum price for such medicines is based on the “initial price” which is defined in regulation 2(1) as the price published by the Department of Health on the internet site www.doh.gov.uk/pprsjuly.htm on 20th January 2000. The maximum price is either the initial price determined by reference to the level of sales for NHS use or a proportion of that price. This level of sales is defined by reference to the sum reimbursed by the PPA in the year ending 30th September 1999. If the sum exceeds £1,000,000 then the maximum price is 95.5 per cent of the initial price: otherwise it is the initial price (regulation 3).

Provision is made for the maximum price to be increased (regulation 4).

These Regulations apply only to those companies which are not members of a voluntary price regulation scheme. The present scheme, agreed on 19th July 1999 between the Department of Health and the Association of the British Pharmaceutical Industry, introduces an overall 4.5 per cent reduction in the prices of branded medicines used by the NHS. Copies may be obtained from the Department of Health, Room 130, Richmond House, 79 Whitehall, London SW1A 2NS (regulation 5(a)).

Medicines listed under Schedule 10 to the National Health Service (General Medical Services) Regulations 1992, which are therefore not generally used within the NHS, are excluded (regulation 5(b)).

Information on the sales of branded health service medicines is required to be kept, and where the Secretary of State so directs, supplied to him (regulation 4 and Schedule 1).

Provision is also made for enforcing the Regulations and paying interest on outstanding payments (regulation 7 and Schedule 2), the recovery of penalties and excess sums (regulation 8 and Schedule 3) and appeals (regulation 10).

A Regulatory Impact Assessment has been prepared and copies may be obtained from the Department of Health, Room 130, Richmond House, 79 Whitehall, London SW1A 2NS. A copy has also been placed in the Library of each of the Houses of Parliament.