Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the 2019 voluntary scheme for branded medicines pricing and access affordability mechanism, whether his Department has conducted an impact assessment on the exemption of smaller companies from the rebate scheme.

The Department analysed the potential effects of the exemptions detailed in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access. However, this analysis did not take the form of a published impact assessment, as that formal process is not required for the voluntary agreement.

The exemption from payments for small companies (sales under £5 million) was also part of the previous voluntary scheme; the 2014 Pharmaceutical Price Regulation Scheme. As such, the Department was already familiar with the scope of the small company exemption in advance of agreement on the 2019 Voluntary Scheme. The Department believes that the continuation of exemptions for small companies and the new approach to medium sized companies (£5 million to £25 million) is appropriate as it supports the growth of the life sciences industry through small and medium sized companies.