natgillin/translations-raw huggingface dataset:
EMa notes the court’s observation but would like to emphasise the following new development since the court’s audit field work in october 2011: the procedure for evaluation of eligibility criteria for patients’ and consumers’ organisations is being revised to include guidance/ criteria with respect to the funding of such organisations. rEply of tHE EuropEaN MEdICINES agENCy 34. 
EMA berie na vedomie pripomienku Dvora audítorov, ale chcela by zdôrazniť nasledujúci pokrok od ukončenia audítorskej práce Dvora audítorov v teréne v októbri 2011: postup hodnotenia kvalifikačných kritérií pre organizácie pacientov a spotrebiteľov sa prehodnocuje, aby zahŕňal usmernenie/kritéria týkajúce sa financovania týchto organizácií.
EMa notes the court’s observation but would like to emphasise the following new development since the court’s audit field work in october 2011: eligibility criteria for healthcare professionals’ organisations have been adopted by EMa Management Board on 15 december 2011 and have been published. 
EMA berie na vedomie pripomienku Dvora audítorov, ale chcela by zdôrazniť nasledujúci pokrok od skončenia audítorskej práce Dvora audítorov v teréne v októbri 2011: správna rada agentúry 15. decembra 2011 prijala a zverejnila kvalifikačné kritéria pre organizácie zdravotných pracovníkov.
EMa notes the court’s observation but wants to emphasise (as recognised by the court in observation number 92) that this is outside EMa’s direct control. 
EMA berie na vedomie poznámku Dvora audítorov, ale chce zdôrazniť (ako uznal Dvor audítorov v poznámke číslo 92), že toto je mimo priamej kontroly agentúry.
EMa has undertaken everything it can do as per its legal mandate, hereby respecting the specificities of the operation and organisation of the Eu regulatory network in the field of medicines regulation. since EMa cannot intervene in the handling by the Member states of the conflicts of interests at national level, two initiatives have been taken by EMa, already in place at the moment of the court’s audit field work in october 2011: — staff and experts at the level of the national competent authorities participating in the (evaluation) work (with respect to the authorisation and surveillance of medicinal products) at national level for services provided to the agency are covered by a Memorandum of understanding (Mou) concluded between EMa and each national competent authority. all Mous were signed by 14 september 2011. — Heads of agencies of the national competent authorities agreed at their meeting in July 2011, at the request of EMa, ‘that EMa standards will constitute the minimum standards of the conflict of interest with any national variations whenever necessary’. 
EMA urobila všetko čo mohla v rámci svojho zákonného mandátu, čím rešpektovala špecifiká fungovania a organizácie regulačnej siete EÚ v oblasti regulácie liekov. Keďže EMA nemôže zasahovať do riešenia konfliktov záujmov členskými štátmi na vnútroštátnej úrovni, agentúra začala už v čase audítorskej práce Dvora audítorov v teréne v októbri 2011 dve iniciatívy: — Na zamestnancov a expertov na úrovni príslušných vnútroštátnych orgánov, ktorí sa na vnútroštátnej úrovni podieľajú na (hodnotiacej) činnosti (pokiaľ ide o povoľovanie a dohľad nad liekmi) na službách poskytovaných agentúre, sa vzťahujú memorandá o porozumení uzatvorené medzi agentúrou EMA a každým príslušným vnútroštátnym orgánom. Všetky memorandá o porozumení boli podpísané do 14. septembra 2011. — Riaditelia agentúr príslušných vnútroštátnych orgánov sa na zasadaní v júli 2011 na žiadosť agentúry EMA dohodli, „že normy EMA budú predstavovať minimálne normy pre konflikt záujmov, v prípade potreby s prípadnými vnútroštátnymi odchýlkami“.
EMa notes the court’s observation but wants to highlight that the conflicts of interests assessment forms for Management Board members have been in use since the past eight years, and declared interests were discussed with the Management Board chairman. since october 2011, the procedures have been further strengthened and the discussions and decisions made on the handling of conflicts of interests are now being recorded by way of minutes. 
EMA berie na vedomie poznámku Dvora audítorov, ale chce zdôrazniť, že počas uplynulých ôsmych rokov sa používali formuláre hodnotenia konfliktov záujmov pre členov správnej rady a deklarované záujmy sa prediskutovali s predsedom správnej rady. Od októbra 2011 sa postupy ďalej upevňovali a diskusie a rozhodnutia prijaté pri riešení konfliktov záujmov sa teraz zaznamenávajú v zápisniciach.
EMa notes the court’s observation but would like to emphasise that a greater confidence in the handling of conflicts of interests can be achieved through full transparency in the field, combined with a robust ex-post control system and a Breach of trust procedure, rather than any prior checking of the correctness of the information declared. 
EMA berie na vedomie pripomienku Dvora audítorov, ale chcela by zdôrazniť, že vyššiu istotu pri riešení konfliktu záujmov možno dosiahnuť skôr pomocou úplnej transparentnosti v tejto oblasti v kombinácii s dôkladným systém spätných kontrol a postupov týkajúcim sa straty dôvery, ako akoukoľvek predchádzajúcou kontrolou správnosti oznámených informácií.
EMa agrees that information provided by the concerned persons (cVs, previous declarations of interests) could be used in the context of such ex-post control system but is not in favour of screening sources of information such as information in media, websites, etc. since this is not considered to be the most cost-effective approach. 
EMA súhlasí, že informácie poskytnuté príslušnými osobami (v životopisoch, predchádzajúcich vyhláseniach o záujmoch) by sa mohli použiť v rámci takéhoto systému spätných kontrol, ale nie je za preverovanie zdrojov informácií, ako sú informácie v médiách, na webových stránkach atď., pretože to nepovažuje za najefektívnejší prístup.
However, any information brought to the attention of EMa at any point in time will be used to check the correctness of the declared interests and, where needed, the appropriate measures will be taken in line with the agency’s policies and procedures, including the Breach of trust procedures. box 6 EMa would like to point out that the examples in Boxes 3 and 6 refer to the same expert. box 8 EMa notes the court’s observation but would like to highlight regarding the second example given in Box 8 that the evaluation of the declaration of interest was a preliminary evaluation carried out in advance of formal implementation of the new EMa policy on the handling of conflicts of interests and subject to confirmatory checks by the agency’s internal declaration of interests advisory Group (diaG). information provided in the initial declaration of interest form was insufficient to allow imposition of any restrictions. further to advice from diaG and additional information from the expert, an evaluation was carried out on the updated declared interests and appropriate restrictions were imposed. rEply of tHE EuropEaN MEdICINES agENCy box 9 EMa notes the court’s observation but would like to point out that a new development has taken place since the court’s audit field work in october 2011: the revised EMa policy on the handling of conflicts of interests of scientific committees’ members and experts (which became effective on 3 april 2012) now clearly states that current direct interests of household members (including financial interests) are taken into account and will lead to restrictions as regards the expert’s involvement in EMa activities, depending on the type of activity and the role of the individual in such activity. 
Všetky prípadné informácie, o ktorých sa však agentúra kedykoľvek dozvie sa použijú na kontrolu správnosti vyhlásených záujmov a v prípade potreby sa prijmú príslušné opatrenia v súlade s politikami a postupmi agentúry vrátane postupov týkajúcich sa porušenia dôvery. Rámček 6 EMA by rada poukázala na to, že príklady v rámčekoch 3 a 6 sa týkajú toho istého experta.
EMa notes that for its staff, annex iX of the staff regulations sets out the basis for administrative enquiries and disciplinary measures including for art 11. 
EMA berie na vedomie, že pre zamestnancov sa v prílohe IX k služobnému poriadku stanovuje základ pre administratívne vyšetrovania a disciplinárne opatrenia vrátane článku 11.
EMa has also adopted implementing rules in line with art 110 on administrative enquiries and disciplinary measures. annex iX also sets out the sanctions applicable to staff. it is not clear that EMa alone could adopt sanctions outside the staff regulations about conflict of interest. 
EMA prijala aj vykonávacie predpisy v súlade s článkom 110 o administratívnych vyšetrovaniach a disciplinárnych opatreniach. V prílohe IX sa ustanovujú aj sankcie uplatniteľné na zamestnancov. Nie je jasné, či samotná agentúra môže prijímať sankcie za konflikt záujmov nad rámec služobného poriadku.
EMa notes the court’s observation and would like to inform the court of the following new developments following the court’s audit field work in october 2011: — a Breach of trust procedure on conflicts of interests for scientific committees’ members and experts has been developed and became effective on 3 april 2012. — a Breach of trust procedure on conflicts of interests for Management Board members has been developed and became effective on 7 June 2012. Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 
Agentúra EMA berie na vedomie pripomienku Dvora audítorov a chcela by Dvor audítorov informovať o nasledujúcom pokroku od ukončenia audítorskej práce Dvora audítorov v teréne v októbri 2011: — bol vypracovaný postup týkajúci sa straty dôvery v súvislosti s konfliktom záujmov pre členov vedeckých výborov a expertov, ktorý nadobudol účinnosť 3. apríla 2012, — bol vypracovaný postup týkajúci sa straty dôvery v súvislosti s konfliktom záujmov pre členov správnej rady, ktorý nadobudol účinnosť 7. júna 2012. Osobitná správa č. 15/2012 – Riadenie konfliktu záujmov vo vybraných agentúrach EÚ
EMa would like to inform the court of the following new developments: in addition to the publication on its website of the declarations of interests of all experts as of 30 september 2011, also the risk level for each expert (assigned on the basis of the information contained in the declaration of interests) is published since 29 february 2012. in addition, declarations of interests of all EMa management have been published on the agency’s website since 29 february 2012. 
Agentúra EMA by rada informovala Dvor audítorov o nasledujúcom pokroku: okrem uverejňovania vyhlásení o záujmoch všetkých expertov od 30. septembra 2011 na webovej stránke, sa od 29. februára 2012 uverejňuje aj úroveň rizika každého experta (priradená na základe informácií uvedených vo vyhlásení o záujmoch). Okrem toho sa od 29. februára 2012 na webovej stránke agentúry uverejňujú aj vyhlásenia o záujmoch celého vedenia agentúry.
EMa would, however, like to emphasise that Management Board minutes contain a section about declarations of interests made at the meeting. this has been in place for several years. 
Agentúra EMA by však rada zdôraznila, že zápisnice zo zasadnutí správnej rady obsahujú časť o vyhláseniach o záujmoch urobených na zasadnutí. Takto to funguje už niekoľko rokov.
With the entry into force of the revised procedure for managing conflicts of interests of Management Board members, restrictions that will apply to individual members are now also being reflected in the published meeting minutes. 
Po nadobudnutí účinnosti revidovaného postupu riadenia konfliktov záujmov členov správnej rady sa v uverejňovaných zápisniciach zo zasadnutí správnej rady začnú uvádzať aj obmedzenia, ktoré sa budú uplatňovať na jednotlivých členov.
EMa notes the court’s observation but would like to emphasise the following new development: on 18 July 2012 EMa has started to make public minutes of the scientific committees (including information on declared conflicts of interests and resulting restricted involvement) in a stepwise approach for all its scientific committees. on 18 July 2012 the first pdco minutes were published, to be followed with the prac and coMp minutes in 3Q2012, and the minutes of all other scientific committees before the end of 2013. 
Agentúra EMA berie na vedomie poznámku Dvora audítorov, ale rada by zdôraznila nasledujúci NOVÝ vývoj: Agentúra EMA okrem toho začala 18. júla 2012 zverejňovať zápisnice zo zasadnutí vedeckých výborov (vrátane informácií o konfliktoch záujmov a vyplývajúcich obmedzených účastiach) v rámci štýlu postupnosti za všetky svoje výbory. Prvé zápisnice PDCO sa zverejnili 18. júla 2012, po nich budú v treťom štvrťroku 2012 nasledovať zápisnice PRAC a COMP a zápisnice všetkých ostatných výborov sa zverejnia do konca roka 2013.
82. art 16 of the staff regulations applies to EMa whereby all departing or former staff are required to inform the agency for two years of their post-employment activities whether paid or not. 
82. Na agentúru sa uplatňuje článok 16 služobného poriadku, podľa ktorého sa od všetkých odchádzajúcich alebo bývalých zamestnancov vyžaduje, aby agentúru dva roky informovali o svojej činnosti po skončení zamestnania, či už platenej alebo neplatenej.
EMa reviews each case and it has imposed restrictions on several staff in respect of their post-employment activities to prevent conflicts of interest arising. a new development since the court’s audit field work in october 2011 is that EMa has extended the application of art 16 of the staff regulations also to trainees, national experts and interims. 
EMA skúma každý prípad a niekoľkým zamestnancom uložila obmedzenia v súvislosti s ich činnosťami po skončení zamestnania, aby sa predišlo vzniku konfliktov záujmov.
(1 february 2012; EMa/78396/2012). all departing staff are reminded in writing of their obligations of confidentiality and the need to apply to EMa regarding any post-employment activities whether paid or not for the two year period. rEply of tHE EuropEaN MEdICINES agENCy 85. EMa notes the court’s observation but would like to emphasise the following new development since the court’s audit field work in october 2011: in its revised policy on the handling of conflicts of interests of scientific committees’ members and experts (which became effective on 3 april 2012) it is stated that when a member of an EMa scientific forum intends to be engaged (either solicited or not) in occupational activities with a pharmaceutical company (such as employment) during the term of the mandate, the member shall immediately inform EMa and refrain from any activities which may have an impact on the pharmaceutical company concerned. in addition, the member shall comply with any additional conditions or limitations EMa may impose. the same provision is provided in the revised policy for Management Board members (which became effective on 3 april 2012). 
ODPOVEĎ EURÓPSKEJ AGENTÚRY PRE LIEKY 85. EMA berie na vedomie pripomienku Dvora audítorov, ale chcela by podčiarknuť nasledujúci pokrok od skončenia audítorskej práce Dvora audítorov v teréne v októbri 2011: v revidovanom prístupe k riešeniu konfliktu záujmov členov vedeckých výborov a expertov (ktoré nadobudli účinnosť 3. apríla 2012) sa uvádza, že keď má člen vedeckého fóra agentúry v úmysle vykonávať pracovnú činnosť (či už vyžiadanú alebo nie) vo farmaceutickej spoločnosti (napríklad zamestnanie) počas ich mandátu, člen má okamžite informovať agentúru EMA a zdržať sa akýchkoľvek činností, ktoré by mohli mať vplyv na príslušnú farmaceutickú spoločnosť.
86. art 16 of the staff regulations applies at EMa whereby all departing or former staff are required to inform the agency for a two year period of their post-employment activities. 
86. Na EMA sa uplatňuje článok 16 služobného poriadku, podľa ktorého sa od všetkých odchádzajúcich alebo bývalých zamestnancov vyžaduje, aby agentúru dva roky informovali o svojej činnosti po skončení zamestnania, či už platenej alebo neplatenej.
EMa reviews each case and it has imposed restrictions on several staff in respect of their post-employment activities to prevent conflicts of interest arising. a new development since the court’s audit field work in october 2011 is that EMa has extended the application of art 16 of the staff regulations also to trainees, national experts and interims (1 february 2012; EMa/78396/2012). all departing staff are reminded in writing of their obligations of confidentiality and the need to apply to EMa regarding any post-employment activities whether paid or not for the two year period. 
Agentúra EMA skúma každý prípad a niekoľkým zamestnancom uložila obmedzenia v súvislosti s ich činnosťou po skončení zamestnania, aby sa predišlo vzniku konfliktov záujmov. Pokrokom od skončenia audítorskej práce Dvora audítorov v teréne v októbri 2011 je, že agentúra EMA rozšírila uplatňovanie článku 16 služobného poriadku aj na stážistov, národných expertov a dočasných expertov.
EMa draws to the court’s attention that a new development since the court’s audit field work in october 2011 is that the Joint committee has issued an opinion, 7/ 2011 of 20 october 2011, which has been made public to EMa staff. this opinion recognises the right of former staff to employment after leaving the agency and the legitimacy of using their skills and experience gained throughout their career. it sets out the compatibility with the interest of the service with regard to specific activities in which EMa staff may engage after leaving the agency. the EMa will keep this Joint committee opinion under review so that the interest of the agency is assured. 
EMA upozorňuje Dvor audítorov, že pokrokom od skončenia audítorskej práce Dvora audítorov v teréne v októbri 2011 je, že Spoločný výbor vydal stanovisko 7/2011 z 20. októbra 2011, ktoré bolo zverejnené zamestnancom agentúry. V tomto stanovisku sa uznáva právo bývalých zamestnancov zamestnať sa po odchode z agentúry a oprávnenosť využívať schopnosti a skúsenosti získané počas kariéry.
96 88. assessment case by case of staff post-employment activities is in place. the legal basis does not apply for EMa to review post-employment of members of the Management Board or scientific committees or experts, none of whom are employed by EMa. 
96 88. Činnosť zamestnancov po skončení pracovného pomeru sa posudzuje od prípadu k prípadu. Tento právny základ agentúra EMA neuplatňuje na preskúmavanie činnosti členov správnej rady alebo vedeckých výborov alebo expertov po skončení zamestnania, keďže žiadny z nich nie je zamestnancom agentúry EMA.
89. 
ZÁVERY A ODPORÚČANIA 89.
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). 
EMA je toho názoru, že primerane zvláda konflikty záujmov, hoci uznáva, že v čase audítorskej práce Dvora audítorov v teréne (október 2011) existoval priestor na ďalšie zlepšenie.
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 above for further information). — 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. rEply of tHE EuropEaN MEdICINES agENCy 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. 
EMA zdôrazňuje najmä tieto aspekty: — Bez ohľadu na chýbajúci regulačný rámec EÚ pre riešenie konfliktov záujmov, agentúra EMA od svojho vzniku uplatňuje právne ustanovenia uplatniteľné na agentúru v tejto oblasti, a preto spĺňa právne požiadavky. EMA okrem toho počas uplynulých 8 rokov nepretržite monitoruje riešenie konfliktov záujmov, analyzuje získané skúsenosti, skúma získané poznatky a vždy, keď je to potrebné, prijíma nápravné opatrenia.
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). — 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). 
EMA tak dokazuje, že berie záležitosť riadenia konfliktov 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 v oblasti riešenia 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.