The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 12-week consultation on proposals to change some of the fees it charges for the regulation of medicines.
These proposals would remove a total of 69 individual fees and reduce fees to industry by 7% overall next year, it says.
The Agency plans to revoke the Medicines (Products for Human Use) (Fees) Regulations (SI 2010 No 551) and remake with amendments to provide a single comprehensive set of regulations in respect of the fees it charges for the regulation of medicines.
Specifically, it is proposing to reduce by 10% the Decentralised Procedure fees in cases where the UK is the Reference Member State (RMS), and remove the current differential fee for electronic submissions (cCTD), reducing fees down to the previously lower eCTD level.
It also plans to simplify the system of periodic fees, removing 13 individual fee types, and simplify parallel import fees by having a single flat fee.
The proposals are designed to provide the industry with “a realistic targeted decrease in fees in terms of the recent economic climate,” and to provide the Agency with a plan “that builds on a strong current position and gives us the resources we expect to need,” it says.
As a Government Trading Fund, the MHRA is required to recover the costs of its medicines regulatory functions through fee income, and the Treasury requires it to achieve a return of at least 3.5% on capital employed. Fees charged by the Agency largely fall into two categories: – “capital” fees, for a particular event, such as a licence application, an inspection or an application for an export certificate; and – “periodic” or “service” fees, payable annually, for the work which it undertakes whilst licences, authorisations and registrations are in force.
For 2012-13, the MHRA estimates that it will derive the following direct capital fees: – £41 million from medicines licensing; – £3 million from clinical trials; – £1 million from manufacturer and wholesale dealer licence applications and variations, plus export certificates; and – £8 million from inspections.
It also expects to derive £27 million from periodic fees, relating to pharmacovigilance, advice and action on “borderline” products, enforcement activities and Commission on Human Medicine and expert advisory groups.
The consultation is now open. It will run to January 31, 2012, and the MHRA plans to introduce the new fees on April 1, 2012.
