EMa thus demonstrates that it takes the issue of management of conflicts of interests very seriously, reviews its policies and the implementation on a continuous basis and takes remedial action whenever necessary. these new developments relate to: — a revised EMa policy on the handling of conflicts of interests of scientific committees’ members and experts which came into effect on 29 september 2011 and was rolled-out during the court’s audit field work in october 2011. the main characteristics of the revised policy are a more robust and transparent system, with stricter requirements in case of direct interests in pharmaceutical industry, stricter requirements for members of decision-making bodies compared to advisory bodies, and stricter requirements for chairpersons/ rapporteurs/ other persons in a lead role compared to other members of the scientific fora. such EMa policy was further revised in 2012 (to give clearer guidance on experts’ involvement in academic trials and publicly funded research, to align restrictions for the different roles in the scientific review process and to tighten the rules on grants from pharmaceutical industry) and became effective on 3 april 2012 (EMa/531078/2010). rEply of tHE EuropEaN MEdICINES agENCy — a revised EMa policy on the handling of conflicts of interests of the Management Board came into effect on 3 april 2012 (EMa/MB/64234/2012) in line with the revised policy for scientific committees’ members and experts. — Breach of trust procedures were developed for both scientific committees’ members/ experts (EMa/154320/2012) (which came into effect on 3 april 2012) and Management Board members (EMa/MB/309079/2012) (which came into effect on 7 June 2012). — transparency on conflicts of interests was further increased through the publication online of the declarations of interests of all experts (on 30 september 2011) and their assigned risk level (on 29 february 2012), and through the publication of the declarations of interests of all EMa management (on 29 february 2012). — on 9 June 2011 EMa adopted rules relating to articles 11a and 13 of the staff regulations concerning the handling of declared interests of EMa employees (EMa/500408/2011) which officially entered into force, following the agreement of the European commission, on 1 february 2012. these rules were subsequently extended by decision of the Executive director of 1 february 2012 to trainees, national experts on secondment, interims and visiting experts (EMa/78396/2012). x. (c) (i) EMa notes the court’s recommendation but would like to emphasise that, in line with EMa’s founding regulation, scientific committees’ members and experts first need to be nominated after which they need to be included in the European expert list (inclusion is only possible once the nomination form, the declaration of interests and confidentiality undertaking form and the curriculum vitae have been submitted). only when this has been completed they may be appointed for involvement in EMa activities, but prior to such appointment an evaluation by EMa of the individual’s declared conflicts of interests takes place, resulting, where applicable, in restricted or refused involvement, depending on the nature of the declared interest, the timeframe during which such interest occurred and the type of EMa activity. this shows EMa had already acted upon this recommendation prior to the court’s audit field work in october 2011. 
EMA tak preukazuje, že berie záležitosť riadenia konfliktu záujmov veľmi vážne, neustále prehodnocuje svoje postupy a ich realizáciu a v prípade potreby podniká kroky smerom k náprave. Tento pokrok sa týka: — Revidovaného prístupu EMA k riešeniu konfliktu záujmov pre členov vedeckých výborov a expertov, ktorý nadobudol účinnosť 29. septembra 2011 a ktorý sa začal vykonávať počas audítorskej práce Dvora audítorov v teréne v októbri 2011.