The Medicines and Healthcare products Regulatory Agency (MHRA) says it is revising its fees for regulatory work from next April 1 with a view to raising its fee income by 3% for 2009-10 and by 4%-6% in the following three years.

These proposals are based on a number of assumptions, including a “healthy order book” for decentralised applications and investments to deliver improved service to MHRA customers, says the Agency, in a consultation letter which details its plans to establish a single set of medicines fee regulations and revoke the current arrangements. A separate consultation is being carried out for medical device regulatory fees.

In the letter, the MHRA says it “has come through a challenging period over the last few years,” with the introduction of new European regulatory requirements, significant restructuring and implementation of the new Sentinel information technology (IT) system. “We have emerged now in a much stronger position both in terms of performance and finances, with a strong and stable platform to build on,” it adds.

The Agency says that in the last two years it has achieved “significant” efficiency gains, equivalent to around 9% per annum, through the settling-in of Sentinel and better processing initiatives which have contributed to achieving the tight timescales imposed by the European regulatory schemes. While it is continuing to recover its performance, it adds: “we recognise that we need to give greater attention to the processing of purely national (UK) applications.”

In 2009-10, the Agency expects to spend £35 million on its medicines licensing activities, and it is proposing to increase by 5.7% the direct capital fees it charges during this period for: all Marketing Applications (MA) and variations, with Type 1A variation fees removed; and – all Product License for Parallel Import (PLPI) applications, with the administrative variation fees removed.

Capital fees for Manufacturers’ Licence/Wholesale Dealers License (ML./WDL) applications, traditional herbal applications, homeopathic registrations, clinical trial applications, WDL daily rate inspections and blood authority/blood bank fees will all go up 4%. The daily rate for all other inspections will be increased by 4.3%, to also cover additional costs relating to the issue of Good Manufacturing Practice (GMP) certificates.

The Agency’s annual service fees for all MAs - new drugs, complex drugs, Prescription-Only Medicines (POM), Pharmacy (P) and General Sale List (GSL) drugs, and parallel imports (PIs) - will go up 8%, while for all other categories - herbal, homoeopathic, ML, WDL, etc – the increase will be 4%.

Among other changes, two new PI fees – Complex and Standard – will be introduced for applications where there is no common origin between the imported and UK reference product. There will also be new brandings for service fees for manufacturers and wholesale dealers which import unlicensed medicines, and a new fee structure for reclassification of medicines from POM to P status, to reflect more accurately the level of work which these activities represent for the MHRA.

For the industry, these proposals offer a more stable medium-term framework of likely overall fee increases and a below-inflation rise for 2009-10, while for the Agency they establish a medium-term plan that builds on its strong current position and gives it the resources which it expects to need, says the MHRA. It is inviting comments on its proposals, to be received by January 7.