Orphans hit as EMA budget freeze puts skids under "Road Map" priorities
This article was originally published in Scrip
The icy winter weather presages a financially chilly 2011 for the European Medicines Agency, whose budget is rising by less than a quarter of a percent amid cuts to its EU funding, an increase in its workload and a freeze on staff levels.
For 2011, the EMA's budget has been set at €208.9 million, a rise of just 0.23% over 2010. Much of this increase is accounted for by revenue from industry fees, which will rise by 5.4% to €161 million.
But revenue from the EU will see a sharp decline: the general EU contribution is falling from €39.1 million to €33.5 million, while the special contribution for orphan medicines (which is used to compensate the agency for orphan drug fee exemptions) is almost halved at €4.9 million. Moreover, no new staff posts are foreseen for 2011.
All this comes at a time when the EMA is facing a growing workload in the form of new responsibilities, new committees and new legislation, either already in place or in the pipeline. For example, it has taken on the evaluation of advanced therapies such as gene and cell therapy, and will soon be assessing more "personalised therapies" involving drugs and companion diagnostics. It will also have a brand new committee on pharmacovigilance from 2012.
Overstretched?
So the agency may find itself quite stretched over the next year: in 2010 a report from Ernst & Young found that the EMA's committee's were already overwhelmed with work and that the whole medicines authorisation system was "progressively attaining its maximum capacity".
Moreover, it will be taking on additional tasks, as outlined in its "Road Map to 2015", which has now been finalised following a consultation process that took into account responses from 71 stakeholders.
Although the Road Map will not be published until January 2011, a good idea of what it will contain can be gleaned from the draft version released at the beginning of this year. Actions proposed include reducing the new drug development attrition rate, monitoring post-approval benefit/risk more efficiently, bringing health technology assessments (HTA) into the drug development process, and analysing the impact of regulatory decisions, such as the effectiveness of risk minimisation measures, on public health.
At least the agency is unlikely to face a greater burden in terms of product applications. In the work programme adopted by its management board together with the budget at its 16 December meeting, it says it expects 97 applications in total next year, just two more than in 2010. 40 of these will be for new human-use medicines (compared with 38 in 2010), 12 for new orphan drugs (14) and 42 for generics (41). The work programme will also be published in January.
Thomas Lönngren departs
At the meeting the management board said farewell to Thomas Lönngren, executive director of the EMA, who is leaving on 31 December after 10 years at the helm.
In a recent interview, Mr Lönngren said the agency had "delivered with high quality from a scientific point of view" despite the almost constant increase in new responsibilities (scripintelligence 20 December 2010).