Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the European Medicines Verification Organisation’s report, NMVO’s Fee Models Status, published on 21 August 2018, what discussions his Department has had with the UK's National Medicines Verification Organisation on reducing the entrance fees for small companies in line with those of other European countries.

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). In their supervisory capacity, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way. As part of that role, the MHRA and the Department have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.

The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other member states NMVO’s across the European Union. It is based on the number of users and cost per connection where larger organisations, which are more likely to have multiple marketing authorisations, pay more. An annual fee waiver scheme exists for micro Marketing Authorisation Holders which is designed to support start-ups and help ensure there is not a barrier to market entry.