UK Concern Over Euro Drug license Fees

The UK Department of health has stressed that European medicine license fees must be sufficient to cover fully the costs to the Medicines Control Agency and the Veterinary Medicines Directorate of their work in the monitoring of drugs with European licenses which are marketed in the UK, and also for certain assessment and inspection duties which the agencies will undertake under contract to the European Medicines Evaluation Agency.

The two agencies are currently reimbursed entirely for their licensing and post-licensing work from license fees paid by industry. This is not the case in most other European Union member states, and means that the fees charged to industry in the UK for these purposes are higher than elsewhere in the EU.

An explanatory memorandum from the Department on European licenses says: "it is important for the UK that the fee levels are sufficient to ensure full reimbursement for these two areas of work."