Download the full outcome
Detail of outcome
The document summarises the feedback to the consultation and outlines the government response, confirming what changes will be made to the statutory scheme.
The main elements of the outcome include:
a price cut of 15%
removal of some exemptions as planned, but replacing these with an exemption to protect small firms (those with NHS sales of less than £5 million) from the price cut and the information provisions
not introducing price cuts to average selling prices or specific provisions for line extensions at this time because of their complexity
revised information requirements being implemented as proposed, so that the necessary information is collected to enable the application of average selling prices at a later date.
There were 79 responses to the consultation, most of which were from the pharmaceutical industry.
A revised impact assessment will be published shortly, and amending regulations will be laid in due course.
This consultation is on proposed revisions to the statutory scheme to control prices of branded NHS medicines to make it work more effectively, and to align it more closely to core parts of the voluntary Pharmaceutical Price Regulation Scheme (PPRS). The statutory scheme covers those companies that decide not to join, or withdraw from, the PPRS.
The proposals include:
introducing a new price adjustment on sales of branded drugs to the NHS
applying the price adjustment to average selling prices in hospitals
removing some of the current exemptions, and introducing a small firms exemption in their place
The draft regulations reflect the proposed changes and, to simplify matters, consolidate the existing regulatory provisions.
The PPRS is negotiated between the government and the pharmaceutical industry to control the prices of branded drugs sold to the NHS. It seeks to achieve good value for money for the NHS, and a fair return for the industry to enable it to research, develop and market new and improved medicines.