Pic: randi.org
By Nathan Devlin 10/27/09
The MHRA has dropped its 2010 licensing fee increase as the pharmaceutical industry suffers from the ensuing economic crisis.
Previously, the Medicines and Healthcare products Regulatory Agency (MHRA) had been projecting a fee increase of three to four percent, but now have revised that plan to increase the fee by just one percent from next April.
Back in October of last year, while the financial services industry was buckling under the strain of a collapsed economy, the pharmaceutical industry - bolstered by a number of assumptions - including a "healthy order book" - said that its proposed three to four percent rise had been "warmly welcomed by industry organisations who have sought a consistent medium-term picture which allows them to budget with confidence."
Now though, with the financial crisis permeating far beyond the boundaries of the financial services industry and into every corner of the global economy, the Agency had revised its figure.
Across the board
According to a consultation letter the MHRA sent out to all stakeholders last week, given the economic climate change since last year’s fees round, in addition to the fact that the financial crisis had led to "forecast volumes of activity and restricting cost increases to become strictly unavoidable," the Agency now recommend only increasing all capital and periodic fees by just 1 percent, across the board.
The letter also detailed how the MHRA forecasts that it will spend GBP£36 million on medicines licensing work during 2010-11 and a further GBP£3 million on the regulation of clinical trials, GBP£1 million dealing with manufacturer and wholesale dealer license applications, variations and export certificates, and GBP£8 million on conducting inspections
Lastly, an additional GBP£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.
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