Executive Summary

On 1 Jan 2019 two new price regulation structures came into effect in the UK: the Voluntary Scheme and Statutory Scheme. These effectively replace the PPRS and Statutory Regulations, respectively. Although most details of the schemes remain intact from previous iterations, there are changes on which MAP have reported. Key insights are available here, showing the announcements of the heads of agreement for the Voluntary Scheme, and the full detail for both Voluntary and Statutory Schemes.

Pre-2019, within the UK, two slightly different pricing arrangements for branded medicines existed, the voluntary Pharmaceutical Price Regulation Scheme (PPRS) and the Statutory Regulations

  • The PPRS was akin to the Voluntary Scheme, negotiated between the ABPI and the DHSC every five years, which aims to limit the growth of branded medicines and is renegotiated every five years. PPRS repayments are triggered if the growth in industry results in the NHS spending more on branded medicines than the agreed level (set by the ABPI and DHSC)
  • The Statutory Regulations imposed a similar rebate scheme to the PPRS, with a final payment percentage of 7.80% on all presentations.