The Health Service Medicines (Control of Prices and Supply of Information) (Amendment) Regulations 2013

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations, which apply to the United Kingdom, amend the Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007 (“the 2007 Regulations”) and the Health Service Branded Medicines (Control of Prices and Supply of Information) (No.2) Regulations 2008 (“the 2008 Regulations”).

Regulation 2 amends the 2007 Regulations, under which any manufacturer or supplier of a branded health service medicine (both those in the Pharmaceutical Price Regulations Scheme, a voluntary price control scheme for branded medicines scheme and those outside that scheme) must provide information to the Secretary of State. The amendments clarify the information on presentations which must be provided from 1st January 2014 and gradually extends the intervals at which information is to be provided from 3 months to 1 year.

Regulation 2(2) inserts a provision which provides that the 2007 Regulations are to cease to have effect at the end of 2020.

Regulation 2(5) substitutes regulation 4 of the 2007 Regulations and inserts a provision that if a penalty is to be applied, but the value of a manufacturer or supplier’s health service sales is not known, the penalty is calculated using the highest rate set out in Column 1 of the Schedule and remains payable at that rate until the manufacturer or supplier provides the information.

Regulation 2(6) inserts new regulation 8 into the 2007 Regulations. It requires the Secretary of State to review the operation and effect of the 2007 Regulations and publish a report within seven years after the Regulations come into force. Following the review it will fall to the Secretary of State to consider whether the Regulations should be revoked or continue in force with or without amendment.

Regulation 3 amends the 2008 Regulations, which control the maximum price of presentations that are supplied for the health services use by any manufacturer or supplier who is not a member of the Pharmaceutical Price Regulation Scheme except where regulation 4 applies. The maximum price is the price for that presentation on 1st December 2013 less 15 per cent, but without regard to any discount or other variation of the price which did not have general application on that date.

The percentage reduction element of the maximum price calculation does not apply to suppliers or manufacturers of branded health service medicines for health service use, from which the derived sales income in relation to those health service sales is less than £5 million.

Regulation 3(3) inserts a provision which provides that the 2008 Regulations are to cease to have effect at the end of 2020.

Regulation 3(6) inserts new regulation 4 into the 2008 Regulations. It sets out the maximum price that applies to low cost presentations, which are solely presentations with a price of less than £2.00 and which are exempt from the percentage reduction in regulation 3.

Regulation 3(7) inserts new regulation 11 into the 2008 Regulations. It requires the Secretary of State to review the operation and effect of the 2008 Regulations and publish a report within seven years after the Regulations come into force. Following the review it will fall to the Secretary of State to consider whether the Regulations should be revoked or continue in force with or without amendment.

Regulation 4 revokes the Health Service Branded Medicines (Control of Price and Supply of Information) Amendment Regulations 2012.

An Impact Assessment has been prepared and is available at www.dh.gov.uk. Copies may also be obtained from the Department of Health, Zone 456D, Skipton House, 80 London Road, London SE1 6LH.