The Medicines and Healthcare products Regulatory Agency (MHRA) says it plans to increase its licensing fees just 1% from next April. Last year, the Agency had been projecting a fee increase of 3%-4%.
In October, the MHRA had announced that it envisaged raising its fee income by 3% for 2009-10 and by 4%-6% in the following three years, based on a number of assumptions including a “healthy order book” for decentralised applications and investments to deliver improved service to its customers. Last week, in a consultation letter sent out to all stakeholders, the Agency noted that the initially proposed 3%-4% rise had been “warmly welcomed by industry organisations who have sought a consistent medium-term picture which allows them to budget with confidence.” However, it added that, given the economic climate change since last year’s fees round, and “allowing for forecast volumes of activity and restricting cost increases to the strictly unavoidable,” it is now proposing to increase all capital and periodic fees by just 1%, across the board, from April 1, 2010.
The Agency is also seeking comments on its proposals to: – introduce a new fee category for marketing applications in European decentralised procedures where the UK is the Reference Member State and the application is submitted under the European Union (EU) “informed consent” procedure; – make some minor changes to the legislation relating to fees; – set a new daily rate fee for risk assessments which do not lead to an inspection of a site; and – extend the payment of the £10,000 fee for “Persons Appointed” hearings to all blood product applications.
In a graphic supplied with the consultation letter, the MHRA forecasts that it will spend £36 million on medicines licensing work during 2010-11. In addition, it will spend £3 million on the regulation of clinical trials, £1 million dealing with manufacturer and wholesale dealer license applications, variations and export certificates, and £8 million on conducting inspections. All these activities are funded by direct capital fees.
A further £29 million will be spent on activities relating to pharmacovigilance, borderline products, enforcement and work with the Commission on Human Medicines (CHM) and expert advisory groups. In the main, these aspects of its work are funded by service fees, except for certain functions in the area of pharmacovigilance – the provision of scientific advice and work on patient information and urgent safety variations – which are covered by direct fees, the Agency notes.
The fee proposals – which, the Agency says, aim to provide the industry with simplification, cost-effectiveness and a lower administrative burden – are open for public comment until January 8, 2010.
