Regulatory Affairs Professional SocietyBy Alexander Gaffney, RAC14 November 2014In a major development, the head of the European Medicines Agency [EMA], Guido Rasi, has been forced to step down by the EU Civil Service Tribunal after adjudicators found that the European Commission had improperly selected him in 2011. The case against Rasi’s appointment was filed by Emil Hristov, formerly with the Bulgarian Drug Agency and a member of EMA’s board, who maintained that EMA and the European Commission had improperly assembled a short list of candidates for the position of EMA’s executive director after the controversial departure of former executive director Thomas Lönngren in 2010. Hristov had applied to the position, but after reaching the interview process for the interview, was ranked last among eight candidates and was not selected to be on a "short list" of candidates presented to EMA’s Board of Directors as being the most suitable for the position. The assembly of that "short list" of candidates by a selection committee was improper, the court found, and the EMA board should have been able to consider the candidacy of Hristov, who they were familiar with.
Therefore, the selection of Rasi by the European Commission is to be annulled, the court ordered. The decision has immediately ramifications for EMA and Rasi, who has been removed from his position and replaced on an acting basis by Andreas Pott, now deputy executive director of EMA. “I note with regret today’s judgment by the European Union Civil Service Tribunal," said Professor Sir Kent Woods, chair of the Management Board, in a statement. "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.”
Both EMA and the European Commission are scrambling to see if the decision can be overturned, they said. The departure of Rasi comes at a particularly tricky time for EMA, which is in the process of implementing a massive change in the way it treats clinical data transparency. Transparency has been one of the hallmarks of Guido’s tenure as EMA’s executive director, and his departure could very well derail some of his signature initiatives.
Andreas Pott Again Tasked with Steadying EMA in Turbulent TimesRegulatory Affairs Professional SocietyBy Nick Paul Taylor20 November 2014Andreas Pott has a habit of being thrust into difficult situations. In 2010, Pott was appointed acting executive director of the European Medicines Agency (EMA) at a time when the regulator was dealing with allegations of conflicts of interest, disputes with the European Parliament and an early row over transparency. Now, Pott is once again in the hot seat during a period of turbulence at EMA. The factors behind Pott’s latest stint as acting executive director relate to the first time he took the role. Back then, Pott held the post during the protracted and messy transition between the reigns of Thomas Lönngren and Guido Rasi. Pott handed the position over to Rasi in late 2011. However, a tribunal has now ruled the European Commission [EC] failed to follow proper recruitment procedures, triggering the annulment of Rasi’s appointment.
Having been forced to remove Rasi from his post, EMA named Pott as acting director. Pott faces the task of implementing new clinical trial legislation, managing the ongoing dispute over data transparency and getting changes to medical device regulation underway. The fallout from disputes in the EC about the oversight of EMA and the resignation of the director-general for health could also affect the regulator. Pott has faced similar circumstances in the past. When Pott last served as acting executive director, he dealt with reports Lönngren was advising pharmaceutical companies, a request from a politician to fire an EMA expert, and a spat with the Nordic Cochrane Centre over the publication of clinical trial data, the Finnegan’s Take blog summarized in 2012. On that occasion, Pott held the post for one year. At this stage it is unclear how long his latest spell will last.
My wife was a US representative on an EU work group and learned very quickly this was all about process not performance. The people involved knew that they were dealing with true bureaucrats who were only interested in process. Some of the nice folks she was dealing with made it clear all of this process was above their pay scale, and they were all for the simple direct approach being offered to solve the various issues involved.
We have gone to France for a number of years and enjoyed a Paris market that had been in service for well over 100 years. The EU decided that this market did not meet current health standards and the only thing to do was issue an immediate shut down order. This would deprive the merchants of an income and the local residents a broader choice of products, but no, the law is the law.
The French being clever installed power outlets that rise from the pavement on market day to supply electric to the refrigeration units in the various stalls. Never mind that people were never getting sick from the fish and other produce, and heaven forbid we sell flowers not kept refrigerated.
Brussels is all about rule and process, common sense takes a back seat to paperwork. Almost sounds like our government.
Steve Lucas
I guess anything upsetting and postponing EMA’s data transparency efforts is welcome to PhRMA and EFPIA, as Guido Rasi’s sudden departure may, regardless of whether they played and payed anyone disgruntled to pull it off or not. Peter Gøtzsche and Robert Whitaker is in Oslo and leave us with no illusions as to what Big Pharma is willing and able to effect, in order to forever make more money, unless regulated and controlled by governments.
Berit,
I wonder those same things. But in spite of his weakening at the end, I suspect he was under a lot of pressure. I hope in time, he’ll tell us what happened. I had some communication with him and found him to be a gracious and thoughtful man.
The Norwegian regulator of medicines was in the panel of the conference in Oslo yesterday, discussing the up to date findings of Gøtzsche and Whitaker, coming directly from the EMA meeting in London. He said nothing about Guido Rasi’s abrupt departure, but conceded that the corruption of medicine is global, that Norway is no exception, and that Sunshine Laws are necessary. I think the law may contribute to opening up the public to the enormity of the fraud perpetrated by Big Pharma, which, by undermining trust in medical science, is also undermining trust in governments ability to govern democratically, defending human rights and justice for all. I told Whitaker that I’m keeping up as best I can, mainly by way of your blog and MIA. We are in agreement on the great value of your work. Thank you!