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.
In order to continue to support innovation and access to new medicines, the 2019 Voluntary Scheme includes a 36 month exemption from payments and freedom of pricing for new active substances (NAS). Under the previous 2014 Pharmaceutical Price Regulation Scheme that ended on 31 December 2018, NASs also had freedom of pricing and exemption from payments, but instead for the five year duration of that scheme. This means that under the 2019 Voluntary Scheme, payments will be received by the Department once that 36-month exemption has ended, sooner than under the previous Scheme, which will then be reinvested in the National Health Service.