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\nEMA’s Top Drug Regulator, Guido Rasi, Forced to Step Down<\/a><\/div>\nRegulatory Affairs Professional Society <\/font><\/strong><\/div>\nBy Alexander Gaffney, RAC<\/div>\n14 November 2014<\/div>\nIn 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<\/a> 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<\/a> 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.<\/p>\n
Therefore, the selection of Rasi by the European Commission is to be annulled, the court ordered<\/a>. 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<\/a>. "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.”<\/p>\n
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<\/a>. Transparency<\/a> has been one of the hallmarks<\/a> of Guido’s tenure as EMA’s executive director, and his departure could very well derail some of his signature initiatives<\/a>.<\/div>\n<\/blockquote>\nAnd he’s been quickly replaced… <\/div>\n\nEuropean Regulatory Roundup: Andreas Pott Takes Over at EMA<\/a><\/div>\nAndreas Pott Again Tasked with Steadying EMA in Turbulent Times<\/font><\/strong><\/div>\nRegulatory Affairs Professional Society <\/font><\/strong><\/div>\nBy Nick Paul Taylor<\/div>\n20 November 2014<\/div>\nAndreas 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<\/a>.<\/p>\n
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<\/a> <\/em>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.<\/div>\n<\/blockquote>\nAnd if you want to read some historical pulp fiction [that happens to be true], don’t miss the Finnegan’s Take<\/a><\/em> blog mentioned above. One might think these matters might be handled with a bit more decorum, but alas, scientists and regulators are people too. As best I can tell, this has little to do with Dr. Rasi, though who knows what’s coming next? It hasn’t made much difference at the EMA so far. Here are a few of last week’s and today’s releases from the EMA:<\/div>\n