Drug companies facing higher fees

EMA Highlights by Gary Finnegan – Pharmaceutical companies will have to pay more to have their new medicines evaluated, if the European Medicines Agency is to balance its budget.

The medicines regulator plans to increase its total expenditure by 4% in 2013, spending €231 million by the end of the year.

It said the higher outgoings will be funded by raising fees charged to companies by a total of €18 million. This would bring the EMA’s total fee income to €179 million, representing a fee hike greater than 10%.

Companies applying for marking authorisations for orphan drugs will face proportionally higher increases. At present, orphan drug applications benefit from a 75% fee reduction but this will be just 40% for non-paediatric products under the Agency’s latest budget plan.

There is no expectation that other sources of income, such as support from the European Union and revenues from the sale of technical publications, will increase substantially. This places much of the funding burden on EMA users seeking marketing approval for new or existing products.

The total spending increase in the latest budget amounts to €9.2 million, much of which is earmarked for EMA staff salaries and operating costs. This is largely due to expansion at the London-based agency which moved to new premises last year and has seen its responsibilities grow in recent years.

EMA executive director Guido Rasi said a review of its organisation is under way to ensure the best use of its staff. This, he said, would mean EMA staff will not be in a position to external meetings – such as conferences – for the first half of 2013.