natgillin/translations-raw huggingface dataset:
ConClusions and reCoMMendations 89. 
ZÁVERY A ODPORÚČANIA 89.
Efsa since 2007 introduced, regularly updated and strengthened in 2011, a comprehensive framework for avoiding potential conflicts of interests, in particular through its robust declarations of interests (doi) policy. 
Úrad EFSA v roku 2007 zaviedol a odvtedy pravidelne aktualizuje a v roku 2011 aj posilnil všeobecný rámec pre predchádzanie potenciálnemu konfliktu záujmov, najmä prostredníctvom svojej komplexnej stratégie vyhlásení o záujmoch (DoI).
Efsa has already planned its regular review for 2013. in the absence of a comprehensive Eu regulatory framework, Efsa has focused its time and resources on the category considered of highest risk – the experts involved in the development and delivery of scientific advice informing policymakers, and Efsa’s staff who support them in this task. 
Úrad EFSA už naplánoval jej pravidelnú revíziu v roku 2013. Vzhľadom na absenciu všeobecného regulačného rámca EÚ úrad EFSA sústredil svoj čas a zdroje na kategóriu spájanú s najväčším rizikom – expertov zapojených do prípravy a poskytovania vedeckých odporúčaní, ktorí informujú zákonodarcov, a na zamestnancov úradu EFSA, ktorí ich podporujú pri plnení tejto úlohy.
Efsa has required the submission of declarations of interest by its scientific experts already in 2003 and laid down a policy on declarations of interest in 2007, which was strengthened in 2011. as an example of the breath of its doi control policy, Efsa, in 2011, screened more than 8,000 annual and specific declarations of interests and scrutinised more than 40,000 agenda items. on 356 occasions experts have been excluded totally or partially of Efsa activities. 
Úrad EFSA vyžadoval od svojich vedeckých expertov predloženie vyhlásení o záujmoch už od roku 2003 a v roku 2007 stanovil stratégiu vyhlásení o záujmoch, ktorá sa v roku 2011 posilnila. Veľký rozsah stratégie DoI dokazuje aj skutočnosť, že úrad EFSA v roku 2011 preskúmal viac ako 8 000 ročných a osobitných vyhlásení o záujmoch a preveril viac ako 40 000 bodov programu.
Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 86 
Osobitná správa č. 15/2012 – Riadenie konfliktu záujmov vo vybraných agentúrach EÚ 86
Efsa Management Board Members will receive a dedicated training on Ethics and integrity in october 2012. 
V októbri 2012 budú členovia správnej rady úradu EFSA musieť absolvovať osobitné školenie o etike a integrite.
98. since 2004, 160 staff members have left Efsa and only 2 have moved to industry in areas covered by Efsa’s remit (restrictions have been imposed in one case). 
Od roku 2004 úrad EFSA opustilo 160 zamestnancov a iba dvaja sa premiestnili do odvetvia v oblastiach, na ktoré sa vzťahujú právomoci úradu EFSA (jednému z nich bolo uložené obmedzenie).
98. (b) criteria implemented since 2007 and further improved in 2011(with the new policy on independence and scientific decision-Making processes and the related implementing acts) by introducing two self-explanatory synoptic tables that describe compatible and incompatible interests. 
98. b) Kritériá uplatňované od roku 2007 a následne zlepšené v roku 2011 (prostredníctvom novej stratégie v oblasti nestrannosti a vedeckých rozhodovacích procesov a súvisiacich vykonávacích aktov) zavedením dvoch samovysvetľujúcich prehľadných tabuliek, ktoré opisujú zlučiteľné a nezlučiteľné záujmy.
98. (c) implemented since 2012 according to the new policy on independence and scientific-decision Making processes issued in 2011 for Efsa staff. 
98. c) Uplatňované od roku 2012 podľa novej stratégie v oblasti nestrannosti a vedeckých rozhodovacích procesov vydanej v roku 2011 pre pracovníkov úradu EFSA.
Efsa would welcome such a comprehensive Eu framework. — for staff members: art. 
Úrad EFSA by uvítal takýto komplexný rámec EÚ.
16, 17, 19 of staff regulation (disciplinary procedure) — for Management Board members (article 15 of the rules of procedures of the Management Board of Efsa, 31 March 2009) Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 87 
16, 17, 19 služobného poriadku (disciplinárne konanie), — v prípade členov správnej rady (článok 15 rokovacieho poriadku správnej rady úradu EFSA, 31. Marca 2009). Osobitná správa č.
88 exeCutive suMMary i. EMa takes note of the court’s report and emphasises that the agency is committed to further improve its handling of conflicts of interests as the agency has done over the past 8 years, hereby complying with the legal provisions on the handling of conflicts of interests applicable to EMa as laid down in its founding regulation, the EMa code of good administrative behaviour and the staff regulations. since the court’s audit field work in october 2011 various initiatives have been taken by EMa (as further elaborated upon in various sections of this report) to further increase the robustness of its procedures and to improve transparency in this field. as a consequence, EMa has already addressed most recommendations made by the court. ii. the oEcd Guidelines are not legally binding on EMa staff, Management Board members, or scientific committees’ members and experts. rEply of tHE EuropEaN MEdICINES agENCy iv. in the absence of an Eu regulatory framework laying down common minimum requirements on the handling of conflicts of interests, EMa has complied with the legal provisions applicable to the agency in this field, as laid down in EMa’s founding regulation, the EMa code of good administrative behaviour and the staff regulations. as regards the use of oEcd Guidelines it should be noted that these are not legally binding on EMa staff, Management Board members, or scientific committees’ members and experts, but EMa in developing its policies and procedures in the field of the handling of conflicts of interests has applied a set of robust principles, compatible with the oEcd Guidelines. v. EMa is of the view that it adequately manages conflicts of interests, although it acknowledges that there was further room for improvement at the time of the court’s audit field work (october 2011). 
88 ZHRNUTIE I. EMA berie na vedomie správu Dvora audítorov a zdôrazňuje, že agentúra je odhodlaná ďalej zlepšovať riešenie konfliktov záujmov rovnako ako v uplynulých 8 rokoch, a tým plniť právne ustanovenia o riešení konfliktov záujmov uplatniteľné v EMA, ktoré sú ustanovené v jej zakladajúcom nariadení, Kódexe dobrého administratívneho správania EMA a služobnom poriadku.
EMa in particular emphasises the following aspects: notwithstanding the absence of an Eu regulatory framework on the handling of conflicts of interests EMa has since its creation implemented the specific legal provisions applicable to the agency in this field, and, as a result, has complied with the legal requirements. furthermore, EMa has over the past 8 years continuously monitored its handling of conflicts of interests, has analysed experience obtained, has looked into lessons learned and taken remedial action whenever necessary. as a consequence, EMa has strengthened the robustness of its handling of conflicts of interests over the past 8 years and has increased transparency in this field (several policies and procedures have been developed and revised over the past 8 years, see below for further information). 
Smernice OECD nie sú pre zamestnancov, správnu radu, ani členov vedeckých výborov a expertov agentúry právne záväzné. ODPOVEĎ EURÓPSKEJ AGENTÚRY PRE LIEKY IV. Keďže neexistuje regulačný rámec EÚ, ktorý stanovuje všeobecné minimálne požiadavky na riešenie konfliktov záujmov, EMA spĺňa právne ustanovenia uplatniteľné na agentúru v tejto oblasti, ustanovené v jej zakladajúcom nariadení, Kódexe dobrého administratívneho správania EMA a služobnom poriadku.
EMa has put in place for its handling of conflicts of interests policies and procedures, which comply with legislation applicable to the agency in this field, and in devel-— oping such policies and procedures has applied a set of robust principles, compatible with the oEcd Guidelines. iii. although research is carried out/ data are provided by pharmaceutical industry, EMa takes into account all available information, including any other data brought to the attention of the agency. all such data are subsequently assessed through a robust scientific review process, which includes evaluation by both a rapporteur and a co-rapporteur and a peer review of the rapporteur/ co-rapporteur assessment at the level of the scientific committee, resulting in collegial opinion-making. therefore, the EMa opinions are based on peer-reviewed science-based assessments, on the basis of all available information (data provided by industry, supplemented by any other data provided to EMa). 
EMA zdôrazňuje najmä tieto aspekty: Na riešenie konfliktov záujmov zaviedla EMA prístupy a postupy v súlade s právnymi predpismi, ktoré sú uplatni-— teľné na agentúru v tejto oblasti, a pri vypracúvaní týchto prístupov a postupov uplatnila súbor jasných zásad, ktoré sú v súlade so smernicami OECD. III. Hoci farmaceutický priemysel realizuje výskum/poskytuje údaje, EMA berie do úvahy všetky dostupné informácie vrátane akýchkoľvek ďalších údajov, ktoré sa dostanú do pozornosti agentúry.
89 — as stated in its policy on the handling of conflicts of interests of scientific committees’ members and experts, when dealing with conflicts of interests there is a need to find the best balance between ensuring that scientific committees’ members and experts participating in EMa activities have no interests in the pharmaceutical industry which could affect their impartiality vis-à-vis securing the best possible scientific expertise. otherwise the problem may shift towards an inferior scientific assessment with negative consequences for the protection of public health and subsequent loss of trust by the general public in EMa’s work. — the court’s audit field work took place in october 2011 and the court’s observations, conclusions and recommendations have been drafted in accordance with the outcome of the audit performed at that time. since the court’s audit field work in october 2011 EMa has taken various new initiatives, addressing already most recommendations made in the court’s report. 
89 — Ako sa uvádza v dokumente agentúry o prístupe k riešeniu konfliktov záujmov členov vedeckých výborov a expertov, pri zaoberaní sa konfliktami záujmov je potrebné nájsť rovnováhu medzi zabezpečením, aby členovia vedeckých výborov a experti zúčastňujúci sa na činnostiach agentúry EMA nemali žiadne záujmy vo farmaceutickom priemysle, ktoré by mohli ovplyvniť ich nestrannosť pri zabezpečovaní najlepšej možnej vedeckej expertízy.
90 in addition, since 29 september 2011 EMa has introduced a compulsory screening of the declared conflicts of interests of scientific committees’ members prior to any formal nomination by the competent authority, in order to inform the nominating authority in advance in case of incompatibility of the declared conflicts of interests with the scientific committee membership, or of the extent of the imposed restrictions. in addition, EMa offers to any nominating authority the possibility of pre-screening by EMa of any expert prior to the formal EMa evaluation for involvement in an EMa activity. 
15/2012 – Riadenie konfliktu záujmov vo vybraných agentúrach EÚ 90 Agentúra od 29. septembra 2011 zaviedla povinné previerky deklarovaných konfliktov záujmov členov vedeckých výborov pred každou oficiálnou nomináciou príslušným orgánom, aby vopred informovala nominačný orgán v prípade nezlučiteľnosti vyhlásených konfliktov záujmov s členstvom vo vedeckých výboroch alebo o rozsahu uložených obmedzení.
However, EMa is of the view that further broadening this concept of screening as recommended by the court is not feasible taking into account the nomination process laid down in EMa’s founding regulation. rather EMa considers that full transparency in the field of the handling of conflicts of interests, combined with a robust ex-post control check and a Breach of trust procedure add more value to a strengthening of the handling of conflicts of interests. 
EMA je však toho názoru, že ďalšie rozšírenie tejto koncepcie previerok, ako odporúča Dvor audítorov, nie je možné vzhľadom na nominačný proces ustanovený v zakladajúcom nariadení agentúry. EMA sa skôr domnieva, že väčšou pridanou hodnotou pre upevnenie riešenia konfliktov záujmov bude úplná transparentnosť v oblasti riešenia konfliktov záujmov v kombinácii s dôkladnými ex-post kontrolami a postupom týkajúcim sa straty dôvery.
EMa has already taken several initiatives along these lines since the court’s audit field work in october 2011, as elaborated upon in various sections of this report. x. (c) (ii) EMa notes the court’s recommendation and emphasises (as recognised by the court in observation number 92) that this is outside EMa’s direct control. 
Od skončenia audítorskej práce Dvora audítorov v teréne v októbri 2011 už podnikla agentúra EMA v tejto súvislosti niekoľko iniciatív, ako je bližšie uvedené v jednotlivých častiach tejto správy. X. c) ii) EMA berie na vedomie odporúčanie Dvora audítorov a zdôrazňuje (ako uznal Dvor audítorov v poznámke číslo 92), že toto je mimo priamej kontroly agentúry EMA.
EMa has undertaken everything it can do as per its legal mandate. the initiatives taken by EMa, and already in place at the moment of the court’s audit field work in october 2011, are: rEply of tHE EuropEaN MEdICINES agENCy (1) a Memorandum of understanding (Mou) (EMa/150487/2012) signed between each national competent authority and EMa putting explicit responsibilities on the national competent authorities on the monitoring of the scientific level and independence of the evaluation carried out by the national competent authorities for services to be provided to EMa. all Mous were signed by 14 september 2011. in the Mou it is explicitly stated that the national competent authorities are responsible for putting in place and maintaining a documented system ensuring that their experts and staff participating at national level in work for services provided to EMa have no financial interests or other interests in pharmaceutical industry which could affect their impartiality. they also have to ensure that any request by the court of auditors and/ or the European anti-fraud office to access/ inspect/ audit records on the handling of conflicts of interests can be accommodated within a reasonable timeframe. 
Agentúra urobila všetko, čo mohla v rámci svojho právneho mandátu. Iniciatívy agentúry, ktoré sa začali a prebiehali v čase audítorskej práce Dvora audítorov v teréne v ok tóbri 2011, sú: ODPOVEĎ EURÓPSKEJ AGENTÚRY PRE LIEKY 1) Memorandum o porozumení (EMA/150487/2012) podpísané medzi každým príslušným vnútroštátnym orgánom a agentúrou EMA výslovne ukladajúce príslušným vnútroštátnym orgánom zodpovednosť za monitorovanie odbornej úrovne a nezávislosti posudkov, ktoré sa majú poskytovať agentúre, vykonávanú príslušnými vnútroštátnymi orgánmi.
(2) at the request of EMa, the agreement reached by Heads of agencies of the national competent authorities at their meeting in July 2011 ‘that EMa standards will constitute the minimum standards of the conflict of interest with any national variations whenever necessary’. x. (c) (iii) EMa notes the court’s recommendation and emphasises that clear and objective criteria have already been put in place by EMa prior to the court’s audit field work in october 2011 and have been strengthened over the past 8 years, most recently in 2012, and are applied consistently through risk mitigation measures (restricted or refused involvement) following evaluation of the declared interests. reference is made to the court’s observation number 58 whereby the court recognises that EMa has the clearest set of assessment criteria and that good practices are applied in EMa for the evaluation of declared conflicts of interests and resulting restrictions, as summarised in annex Vi to this report. 
2) na žiadosť EMA, dohoda dosiahnutá medzi riaditeľmi agentúr príslušných vnútroštátnych orgánov na ich zasadaní v júli 2011, „že normy EMA budú predstavovať minimálne normy pre konflikt záujmov, v prípade potreby s prípadnými vnútroštátnymi odchýlkami“.
Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 91 x. (c) (v) EMa notes the court’s recommendation and would like to emphasise that the following new initiatives have been taken since the court’s audit field work in october 2011: — a Breach of trust procedure for scientific committees’ members/ experts has been developed and came into effect on 3 april 2012. — a Breach of trust procedure for Management Board members has been developed and came into effect on 7 June 2012. — the staff regulation applies to EMa staff. article 13 provides for transfer of staff where spouse employment creates a conflict of interest. at EMa the supplementary sop/EMa/0101 sets out the procedure to follow to assess and to mitigate conflict through restricting the work of the conflicted staff member. article 9, annex iX lists the sanctions that may be applied. article 23, annex iX provides for suspension of a staff member. implementing rules on administrative enquires and disciplinary procedures (EMa 7/20.8, 8 June 2012) govern an administrative enquiry. 
15/2012 – Riadenie konfliktu záujmov vo vybraných agentúrach EÚ 91 X. c) v) EMA berie na vedomie odporúčanie Dvora audítorov a chcela by zdôrazniť, že od audítorskej práci Dvora audítorov v teréne v októbri 2011 sa začali tieto NOVÉ iniciatívy: — bol vypracovaný postup týkajúci sa straty dôvery pre členov vedeckých výborov/expertov, ktorý nadobudol platnosť 3. apríla 2012, — bol vypracovaný postup týkajúci sa straty dôvery pre členov správnej rady, ktorý nadobudol platnosť 7. júna 2012, — pre zamestnancov agentúry platí služobný poriadok.
EMa has put in place for its handling of conflicts of interests policies and procedures, which comply with legislation applicable to the agency in this field, and in developing such policies and procedures has applied a set of robust principles, compatible with the oEcd Guidelines. 
EMA zaviedla na riešenie konfliktov záujmov prístupy a postupy v súlade s právnymi predpismi, ktoré sú uplatniteľné na agentúru v tejto oblasti, a pri vypracúvaní týchto politík a postupov uplatnila súbor jasných zásad, ktoré sú v súlade so smernicami OECD.
Involvement of external experts: EMa notes the court’s statement but would like to emphasise that although the members of the scientific committees are involved in the drafting of scientific opinions, such scientific opinions go through a peer review process and subsequent collegial opinion-making within the scientific committees. 
Účasť externých expertov: EMA berie na vedomie vyhlásenie Dvora audítorov, ale rada by zdôraznila, že hoci sa členovia vedeckých výborov podieľajú na vypracúvaní vedeckých stanovísk, tieto vedecké stanoviská podliehajú procesu partnerského preskúmania a následne spoločnému prijímaniu stanovísk vedeckými výbormi.
EMa notes the court’s statement but refers to EMa replies under points 1 and 10. 
EMA berie na vedomie vyhlásenie Dvora audítorov, ale odvoláva sa na svoje odpovede uvedené v bodoch 1 a 10.
15. EMa notes the court’s statement but refers to EMa reply under point 7, 3rd indent. (partnership with stakeholders). 
ROZSAH AUDITU A AUDÍTORSKÝ PRÍSTUP 15. EMA berie na vedomie vyhlásenie Dvora audítorov, ale odvoláva sa na svoju odpoveď uvedenú v bode 7 tretej zarážke. (Partnerstvo so zainteresovanými stranami).
EMa notes the court’s statement but would like to emphasise that the oEcd guidelines are not legally binding on EMa staff, Management Board members, or scientific committees’ members and experts. in the absence of an Eu regulatory framework laying down common minimum requirements on the handling of conflicts of interests, EMa has complied with the legal provisons applicable to EMa in this field as laid down in EMa’s founding regulation, the EMa code of good administrative behaviour and the staff regulations. 
EMA berie na vedomie vyhlásenie Dvora audítorov, ale chcela by zdôrazniť, že smernice OECD nie sú pre zamestnancov, členov správnej rady, ani členov vedeckých výborov a expertov agentúry právne záväzné. Keďže neexistuje regulačný rámec EÚ, ktorý by ustanovoval všeobecné minimálne požiadavky riešenia konfliktov záujmov, agentúra EMA spĺňa právne ustanovenia uplatniteľné pre agentúru EMA v tejto oblasti, ktoré sú ustanovené v jej zakladajúcom nariadení, v Kódexe dobrého administratívneho správania EMA a v služobnom poriadku.
EMa has, when developing its policies and procedures on the handling of conflicts of interests, applied a set of robust principles, compatible with the oEcd Guidelines. 
EMA uplatňuje pri vypracúvaní svojich prístupov a postupov na riešenie konfliktu záujmov súbor jasných zásad, ktoré sú v súlade so smernicami OECD.
28. 
PRIPOMIENKY 28.
EMa notes the court’s statement but would like to emphasise that these rules only apply to staff employed and paid by EMa. it is not possible to apply them to persons designated ‘ad personam’ (not employed by EMa) such as Management Board/ scientific committees’ members, as well as experts. 
EMA berie na vedomie vyhlásenie Dvora audítorov, ale chcela by zdôrazniť, že tieto pravidlá sa uplatňujú len na zamestnancov, ktorých zamestnáva a platí EMA.
Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 93 furthermore, there is a new development, which was rolled-out during the court’s audit field work in october 2011: since 29 september 2011 a compulsory screening by EMa has been introduced of the declared conflicts of interests of scientific committees’ members prior to any formal nomination by the competent authority, in order to inform the nominating authority in advance in case of incompatibility of the declared conflicts of interests with the scientific committee membership, or of the extent of the imposed restrictions. in addition, the possibility of pre-screening by EMa of any expert prior to the formal EMa evaluation for involvement in an EMa activity is offered to the nominating authority. 
15/2012 – Riadenie konfliktu záujmov vo vybraných agentúrach EÚ 93 Okrem toho existuje pokrok, ktorý začal počas audítorskej práce Dvora audítorov v teréne v októbri 2011: od 29. septembra 2011 zaviedla agentúra EMA povinné previerky deklarovaných konfliktov záujmov členov vedeckých výborov pred každou oficiálnou nomináciou príslušným orgánom, aby vopred informovala nominačný orgán v prípade nezlučiteľnosti deklarovaných konfliktov záujmov s členstvom vo vedeckých výboroch alebo o rozsahu uložených obmedzení.
EMa notes the court’s observation but would like to point out that in the cases where interests are incompatible with existing policies, nominating authorities are informed of such cases and, in the past steps have been taken by a candidate to divest interests before becoming Management Board member (december 2011). box 3 EMa would like to point out that the examples in Boxes 3 and 6 refer to the same expert. as highlighted in the EMa reply to point 28 the situation has changed: in the appointment procedure whereby calls for expression of interest were launched in september 2011 for the appointment notably of civil society representatives in 3 scientific committees and the Management Board, the declarations of interest have been submitted and evaluated prior to appointment. similarly, where there was a situation where the appointment by a Member state was incompatible with Management Board membership, the nominating authority was informed and the person concerned divested the interests before becoming a Management Board member (december 2011). 
Agentúra EMA berie na vedomie vyhlásenie Dvora audítorov, ale chcela by poukázať na to, že v prípadoch, ak sú záujmy nezlučiteľné s existujúcimi prístupmi, nominačné orgány sú informované o týchto prípadoch a v minulosti uchádzač podnikol kroky, aby sa vzdal týchto záujmov pred vymenovaním za člena správnej rady (december 2011).