Controversy as EU regulator quits

by Gary Finnegan: The European Medicines Agency finds itself, not for the first time, entering a new year surrounded by uncertainty over the future of its leadership.

The EMA Management Board held an extraordinary meeting in early December in the wake of the departure of executive director Guido Rasi. Professor Rasi had been forced to step down after an EU tribunal found errors had been made during his appointment.

The ‘procedural error’ relates to how the European Commission drew up a shortlist for the position in 2011.

“It is important to remember that the ruling is about a procedural formality. It is not a reflection on Guido Rasi’s competence or ability to run the Agency, something which he has done successfully since November 2011,” said Professor Sir Kent Woods, chair of the Management Board.

Bulgarian drug regulator Emil Hristov – who previously served on the EMA board – had appealed against Rasi’s appointment on the grounds that the shortlisting of candidates was ‘improper’.

Hristov had been ranked eighth on a list of eight people interviewed for the post but his name was not included in the final group of candidates presented to the EMA board. The case had been hanging over the Agency for three years at a time when it has been working to balance rising demands on its resources.

The European Union Civil Service Tribunal annulled Rasi’s appointment, leading to his sudden departure.

Deputy Executive Director, Andreas Potts, will run the agency until a new recruitment process can be begun. Potts had previously served as interim director prior to Rasi’s appointment.

The appointment of a permanent figurehead in 2011 followed a period of almost a year where the drug watchdog was in limbo over the recruitment of an executive director. The delay stemmed, at least in part, from a stand-off between the EMA and the European Commission over the pay grade attached to the post.

There were other challenges too. The Agency’s former chief, Thomas Lönngren, had stepped down at the end of 2010 but by mid-2011 was mired in controversy over consultancy work he had taken up after his EMA contract ended. 

The EMA board publicly reminded Lönngren that conflict-of-interest rules apply to former executives for two years after they have left their post.

All of this was a distraction from much-needed reforms at the Agency which was also in the process of moving to a new office in London. In comparison, the three-year reign of Professor Rasi has been a period of relative calm.

The European Commission said it would now move to publish an advertisement for the vacancy. It remains to be seen whether Rasi, Hristov, or even Potts will seek to be shortlisted.