LONDON – The EMA will welcome back Guido Rasi as executive director almost 12 months after suspending him from the post when his appointment was annulled three years into a five-year term.

In November 2014, the EU Civil Service Tribunal found Rasi's selection in 2011 was invalid because the recruitment process was not objective. Now, following a new process, the EMA management board has once again nominated him for the post.

Rasi will get his old job back subject to satisfying the European Parliament Committee dealing with health issues, at a hearing on Oct. 13.

Kent Woods, chair of the EMA management board said the decision "is the result of a robust recruitment process" adding, "We look forward to Professor Rasi resuming his leadership of the agency."

Andreas Pott, deputy executive director, has nominally been leading the EMA since the tribunal ruling. But although suspended from the executive director post, Rasi has continued to work at EMA and to represent it on panels and at conferences.

As principal advisor in charge of strategy he was de facto host of the EMA's 20th anniversary conference in March, opening the meeting and setting down key challenges for the agency in future. (See BioWorld Today March 19, 2015.)

The EMA management board selected Rasi from a short list of candidates drawn up by the EC.

The tribunal ruling that led to Rasi's suspension came about as a result of an appeal lodged by a rival for the job of executive director, Emil Hristov, who was Bulgaria's representative on the management board of the EMA from January 2007 to April 2009.

Hristov was offended at not making the short list of candidates for the post of executive director when Rasi was first appointed in 2011. He complained on the grounds that the selection process was unfair because two people sitting on the EC panel that drew up the short list also were members of the management board of the EMA, which made the decision to appoint Rasi.

The tribunal found in favor of Hristov, annulling the recruitment process and rendering Rasi's appointment invalid.

This storm in an administrative teacup – and the 10 months it has taken to resolve the situation – has been an embarrassment both to the EMA and the EC. With no suggestion that he was anything other than a suitable and effective head of the EMA, the removal of Rasi was widely seen as grossly unjust and disproportionate. There is little surprise and some relief he is finally to be reinstated.

Rasi signaled he intends to pick up where he left off with his attempts to streamline and modernize EMA's approval processes, saying the agency must rise to the challenge of meeting patients' legitimate expectations for access to new and safe therapeutic options.

"This requires that the medicines authorization process not only supports the early stages of research and development, but also strives to make the best possible use of real world data throughout a medicine's life cycle," Rasi said.

EMA CONSULTATION ON UPDATED IMMUNOGENICITY TESTING

In other news from the EMA, a public consultation has opened on the guideline for assessing the immunogenicity of protein drugs, following its revision to reflect experience to date and encompass ways of assessing a growing number and diversity of protein-based products.

The guideline includes more specific requirements for assays for immunogenicity and integrated analyses of the clinical significance of any immunogenic reaction.

One of the key issues the EMA wants the updates to address is the low predictive value of animal studies in assessing likely immunogenicity in humans.

In addition, the agency wants immunogenicity testing to better reflect the influence of factors such as genetic background, age, pre-existing immunity, immune status and route of administration that can show considerable variation between subjects.

The consultation is open until Jan. 31, 2016.