Pharmaceutical price regulation scheme 2014
A 5-year voluntary scheme on the control of prices agreed between government and the Association of the British Pharmaceutical Industry (ABPI).
Latest change: Responsibility for administering Patient Access Schemes (PAS) now sits with NHS England instead of DHSC. Wording in chapter 5 updated to reflect this change.
AI Summary
The 2014 Pharmaceutical Price Regulation Scheme (PPRS) was a voluntary agreement established between the UK Department of Health and the Association of the British Pharmaceutical Industry (ABPI) to regulate the cost of branded medicines for the National Health Service (NHS). This regulatory framework aimed to balance the need for affordable medicine with the desire to support a thriving pharmaceutical industry. The scheme detailed the conditions for membership, flexible pricing strategies, and patient access schemes designed to facilitate the availability of high-cost treatments. A critical component of the agreement was the PPRS payment mechanism, which required participating companies to make financial contributions to the Department of Health if the total NHS spending on branded medicines exceeded specified growth targets. Additionally, the document clarified how spending from the Cancer Drugs Fund would be accounted for under these financial limits. The guidance also outlined acceptable levels of profit return, capital investment allowances, and formal protocols for resolving disputes between the government and industry partners. While the 2014 PPRS provided the foundational rules for pricing and access during its tenure, it has since been superseded by the 2019 Voluntary Scheme for Branded Medicines Pricing and Access. Therefore, the required actions for pharmaceutical companies now involve transitioning to the updated 2019 framework to ensure continued compliance with UK pricing regulations and rebate obligations.
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