Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 18 June 2015 | By Michael Mezher
The European Medicines Agency (EMA) is pressing forward with its plans to appeal a decision that annulled the appointment of its former executive director, Guido Rasi, Politico reports.
On 13 November 2014, after hearing claims by Emil Hristov, who sought the executive director spot alongside Rasi in 2010, the EU Civil Service Tribunal ruled parts of the selection process were improper due to the composition of the pre-selection panel.
During the hiring process, the pre-selection stage was to be conducted by the European Commission (EC), and the final selection decision was to be made the EMA Management Board. However, two members of the pre-selection panel were members of the EMA Management Board, which the tribunal found to infringe on the panel's "duty of impartiality." As a result, Rasi was forced to step down as executive director, leaving Andreas Pott as acting director.
In the immediate aftermath, EMA said the tribunal's ruling was "on purely formal grounds," and that the agency would look at options for legal recourse. Shortly afterward, Rasi was appointed as principle adviser in charge of strategy at the agency.
In the few months after the tribunal ruling forced Rasi to step down as executive director, EMA has braced itself for two potential futures.
In December 2014, the agency launched its search for Rasi's replacement, and one month later filed an appeal against the tribunal's ruling to the EU's highest court.
In the appeal, EMA and the EC allege the Civil Service Tribunal took matters too far, and that the tribunal's ruling was not proportional or balanced.
"The Civil Service Tribunal infringed EU law by attributing the principle of good administration a scope which it does not have;in the alternative, the Civil Service Tribunal infringed the principle of proportionality by failing to determine, before making the annulment, whether the failure to observe the principle of good administration could have affected the contents of the contested decision;in the further alterative, the Civil Service Tribunal, in any event, infringed EU law by failing to balance the respective interests an failing to limit the effects of its judgements."
"The Civil Service Tribunal infringed EU law by attributing the principle of good administration a scope which it does not have;
in the alternative, the Civil Service Tribunal infringed the principle of proportionality by failing to determine, before making the annulment, whether the failure to observe the principle of good administration could have affected the contents of the contested decision;
in the further alterative, the Civil Service Tribunal, in any event, infringed EU law by failing to balance the respective interests an failing to limit the effects of its judgements."
In the meantime, it seems EMA is taking a wait and see approach. The application window for the executive director position is closed, and at this time a date for the appeal hearing has not been set. However, if the appeal is successful, EMA is asking the court to set aside the previous judgement and "refer the case back to the Civil Service Tribunal."
EMA Appeal, Politico
Tags: Guido Rasi, Civil Service Tribunal