EMA raises drugmaker fees and plans rejig

The European drug regulator published its 2013 budget​ earlier this week, forecasting that it will spend some €231m ($302m) in the year to December 31, which is a 4 per cent increase on its outlay in 2012.

To fund the hike the regulator plans to increase what it charges drugmakers to assess their candidate drug products. The aim is to generate fee revenue of €179m this year, which is an increase of €18m on the amount collected in 2012.

The EMA will also increase what it charges for Orphan Drugs, reducing the current 75 per cent fee reduction it offers companies developing non-paediatric products to 40 per cent​.

In contrast, the agency does not expect the contribution from other potential funding sources – the European Union, revenue from the issuance of export certificates or money from the sale of technical publications – to increase significantly.

The spending increase – some €9.2m – will be used to fund increases in EMA staff basic salaries, with a further €7m being spend ‘salary weightings’ that take into account employee experience or location.

Reorganisation​

The release of the 2013 budget follows just a few weeks after the Agency announced a review of its operations and processes that is designed to increase efficiency and make best use of resources.

The plan – which the EMA said it expects to result in a significant reorganisation of its staff during 2013 – will involve staff from across the agency and will prevent the agency from contributing to external meetings until later this year.

Agency executive Director Guido Rasi said: “The aim of this exercise is to improve our processes and how best to use our resources, not least to ensure that we are better prepared for future legislative and policy challenges.​

“I apologise in advance to event organisers for any disappointment this may cause in the months ahead​.”