OBJECTIVES: To analyse key differences between the recently negotiated Pharmaceutical Price Regulation Scheme (PPRS) and previous schemes.  Understanding the implications of these changes is important for the pharmaceutical industry and pricing and reimbursement (P&R) activities, particularly when considering the application of risk-sharing.    METHODS: The new and old versions of the PPRS were compared across several dimensions: 1) price cuts; 2) price and profit controls; 3) new initiatives; and 4) incentives.  In particular, the recent introduction of “patient access schemes” (PASs) was examined.  Recent risk-sharing agreements (Velcade and Lucentis) were presented as case studies.  To provide an international perspective and cross-market comparison, the analysis also considered examples of risk-sharing schemes as used in other countries. RESULTS: In terms of price cuts, the new PPRS is a continuation of previous schemes encompassing a 6-7% reduction.  Price modulation and profit controls remained unchanged. However, flexible pricing, which encourages companies to initially set lower prices to gain approval and increases prices as more evidence of effectiveness emerges, has been introduced.  The most important difference concerns the introduction of PASs, which build on the idea of risk-sharing.  Velcade and Lucentis provide useful examples of different approaches: the former defining risk in terms of “patient response” (outcomes-based) and the latter according to treatment utilisation (financial-based).  Both schemes continue to be active.     CONCLUSIONS: The new PPRS signifies an important shift in the UK policy framework.  The introduction of PASs raises issues about scheme implementation and how risk should be measured and tracked overtime.  The progress of this initiative will shape the renegotiation of the next PPRS and the setting of future priorities.  However, it is likely that “value-based pricing” – however defined and understood – will continue to gain momentum.