To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 5 June (HL8118), what assessment they have made of the impact the policy of requiring companies who are Marketing Authorisation Holders (MAHs) to pay identical set up and annual operational fees regardless of the size of those companies will have on (1) the competitiveness of smaller companies, and (2) barriers to market entry for prospective new MAHs; and whether they plan to ask the Competition and Markets Authority to carry out such an assessment.
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 Department and the Medicines and Healthcare products Regulatory Agency’s (MHRA) aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way and this includes consideration of their fee structure.
Our assessment is that the fee model and waiver that SecurMed is using is:
- Based on a template (blue print) developed by stakeholders at a European level and published by the European Medicines Verification Organisation (EMVO);
- In line with the model being used by other European Union countries; and
- Based on the number of users and cost per connection as the main drivers of the cost of the NMVO system, where larger organisations which are more likely to have multiple marketing authorisations pay more.
The annual fee waiver scheme for micro Marketing Authorisation Holders is designed to support start-ups and help ensure there is not a barrier to market entry. The fee model is part of the implementation of the ‘safety features’ element of the Falsified Medicines Directive, which is based on a European wide medicines supply chain stakeholder led model.
In a supervisory capacity, the Department and the MHRA’s scrutiny includes:
- EMVO’s blue print resulting from their assessment of different cost-allocation models;
- Aligning the UK’s approach with other EU NMVOs; and
- Seeking to ensure that the fee model is fit for purpose for the UK.
We are not seeking changes to the fee model at this time and have no plans to carry out any additional assessment or request that the Competition and Markets Authority make an assessment.