To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 5 June (HL8118), whether they plan to (1) amend the Marketing Authorisation Holder fee waiver scheme in line with the Pharmaceutical Price Regulation Scheme (PPRS); and (2) exempt any companies with NHS sales below £5 million; and for what reasons the conditions for SecurMed’s fee waivers differ from those of the PPRS.
SecurMed, the not-for-profit company, set up by stakeholders in the United Kingdom medicines supply chain, is responsible for setting the fee model and level of fees as the UK’s National Medicines Verification Organisation (NMVO). We understand that SecurMed do not want to amend the waiver scheme in line with the Pharmaceutical Price Regulation Scheme (PPRS) or exempt companies with National Health Service sales of below £5 million. As a not-for-profit company, if SecurMed’s income exceeds its needs, the excess will need to be returned to Marketing Authorisation Holders.
The PPRS is a voluntary agreement negotiated on NHS medicines selling prices and managed by the Department for the UK.
The fee waiver scheme is part of the implementation of the ‘safety features’ element of the Falsified Medicines Directive that is based on a European wide medicines supply chain stakeholder led model. The flat fee model they are using is based on a template (blue print) developed by stakeholders at a European level and published by the European Medicines Verification Organisation. The number of users and cost per connection is the main driver of the cost of the NMVO system. On that basis, the flat fee model was developed with a single fixed fee per marketing authorisation or connection.