EMA Expects OK for 2.6% Fees Hike in 2013

The agency made the prediction earlier this month in a notice issued to remind drugmakers of the likely changes ahead of the annual increase.

It said that: “The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with the 2012 inflation rate. Although the final adjustment is not yet known, the Agency expects its fees to increase by around 2.6%.”​

The EMA also said that it will publish full details of the new fees before the end of the month once the changes have been adopted by the European Commission and that submissions made before March 31 will be subject to the 2012 tariff.

The European drug watchdog first mentioned the price hike in its 2013 budget, which it released on December 31​. At the time it said that it hoped to generate an additional €18m ($23m) through the increase, explaining that the charges would be related to the assessment of new drugs.

The EMA also said it would increase what it charges developers of Orphan drugs by reducing the current 75 per cent fee reduction it offers such firms. 

A proportion of the additional revenue will be used to fund staff salary increases and salary weightings based on employee location.

The fee forecast comes as the EMA continues to review its operations. The process began in December last year when the agency said that it will focus “on increasing the efficiency of its scientific activities and information- and communication-technology operations.”

Further details of this process have not been disclosed – although the agency said it “expects this process to result in a significant reorganisation of its staff during 2013.” 

The EMA’s management board will meet on March 20 in London, UK.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) told in-Pharmatechnologist.com it "believes that the EMA should be adequately-funded to fulfill its public health mission to EU citizens. It is also important that the Agency is supported in responding to advances in science which can improve patient health. However the level of charges applied to industry should remain reasonable and help foster innovation in the EU."

The industry group also said that: "It is at this time not completely clear where the EMA will charge for more, " and added that "we have not have comments from our members at this time."