Question to the Department of Health and Social Care:

To ask Her Majesty’s Government why the protection afforded to small and medium-sized enterprises with sales between £5 million and £25 million under the previous Pharmaceutical Price Regulation Scheme has not been carried forward into the new scheme.

The 2014 Pharmaceutical Price Regulation Scheme (PPRS) was agreed with the Association of the British Pharmaceutical Industry. It did not include the exemption from certain requirements for companies with health service sales of between £5 million and £25 million a year that were a feature of the 2009 PPRS. However companies with sales of health service medicines of less than £5 million a year (not counting global sales) are exempt from making any payments under the 2014 PPRS scheme.

The PPRS benefits businesses making new medicines. A company that develops and brings a new medicine (new active substance) to the market from 1 January 2014, does not have to make PPRS payments to Government on the sales of these new medicines for the lifetime of the 2014 scheme. This particularly helps companies which only have new, innovative medicines in their portfolio.

The Government remains committed to ensuring that the United Kingdom is a world leading place for life science research and investment through the Strategy for UK Life Sciences. The Department has assessed the impact of the PPRS and does not believe that there will be any significant impact on research and development investment in the UK.