natgillin/translations-raw huggingface dataset:
61. in relation to gifts, Efsa has for many years applied the framework provided by the European commission on ethics and integrity, and has adopted a specific policy in July 2012. 
61. När det gäller gåvor har Efsa i många år tillämpat Europeiska kommissionens regelverk om etik och integritet och antog en särskild policy i juli 2012.
Breach of trust procedures have been defined and implemented for the following categories of population: — for all experts (scientific committee, scientific panels and Working Groups) (‘implementing act to the policy on declaration of interests – Guidance document on declarations of interest, page 7; signed 8 september 2009’). — for staff members: art. 
Förfaranden vid förtroendebrott har utformats och tillämpats för följande kategorier: — Samtliga experter (vetenskapliga kommittén, vetenskapliga paneler och arbetsgrupper) (”Genomföran-deakt till policyn för intresseförklaringar – vägledning om intresseförklaringar”, s.
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) it is important to highlight that in the case a breach of trust of a Management Board member, Efsa has to refer to the appointing authority (council) since the Executive director cannot dismiss a member of the Management Board. rEply of tHE EuropEaN food SafEty autHorIty 72. in line with its 2007 policy and rules of operation of scientific committee/scientific panels all declarations of interest (doi) and minutes of the meetings, including assessment of doi, are published on Efsa’s website. 
7, undertecknad den 8 september 2009”). — Personal: artiklarna 16, 17 och 19 i tjänsteföreskrifterna (disciplinärt förfarande). — Styrelseledamöter (artikel 15 i arbetsordningen för Efsas styrelse, den 31 mars 2009). Det är viktigt att påpeka att om en styrelseledamot gör sig skyldig till ett förtroendebrott måste Efsa vända sig till tillsättningsmyndigheten (rådet), eftersom den verkställande direktören inte får avskeda en styrelseledamot.
88. and box 10 the review by the ombudsman of the allegation of revolving doors is ongoing. it must be noted that since 2004, 160 staff members have left Efsa and only 2 have moved to industry in areas covered by Efsa’s remit (one has been imposed restriction). since 2010 Efsa has been actively seeking information on post-employment status from departing staff and has designed a specific process for assessing and if necessary imposing restrictions. 
Det bör noteras att 160 anställda har lämnat Efsa sedan 2004 och att endast två har gått till industrin inom områden som täcks av Efsas ansvarsområde (en av dem har fått begränsningar). Sedan 2010 har Efsa aktivt sökt information om vilken anställning avgående och tidigare personal gått vidare till och har utformat en särskild process för bedömning och begränsningar, om sådana visar sig nödvändiga.
Efsa is fully in line with the provisions of article 16 of the staff regulations. 
Efsa följer helt och hållet bestämmelserna i artikel 16 i tjänsteföreskrifterna.
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. 
Efsa har redan planerat den regelbundna översynen för 2013. Eftersom EU saknar ett övergripande regelverk har Efsa koncentrerat sin tid och sina resurser på den kategori som anses utgöra ett högriskområde, nämligen de experter som deltar i utveckling och förmedling av vetenskapliga råd till beslutsfattare liksom den personal vid Efsa som stöder dem i denna uppgift.
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. 
Efsa har alltsedan 2003 krävt att myndighetens vetenskapliga experter ska lämna en intresseförklaring och utformade 2007 en policy för intresseförklaringar som stärktes 2011. Som ett exempel på bredden i policyn för intresseförklaringar gjorde Efsa under 2011 granskningar av fler än 8 000 årliga och specifika intresseförklaringar och undersökte nästan 40 000 dagordningspunkter.
Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 86 
Särskild rapport nr 15/2012 – Hantering av intressekonflikter vid utvalda EU‐organ 86
94. invitation policy implemented since 2009 in Efsa. in relation to gifts, Efsa has for many years applied the framework provided by the European commission on ethic and integrity, and has adopted a specific policy in July 2012. recommendation 6 Breach of trust procedures have been defined and implemented for the following categories of population: — for all experts (scientific committee, scientific panels and Working Groups) (‘implementing act to the policy on declaration of interests – Guidance document on declarations of interest, page 7; signed 8 september 2009’). rEply of tHE EuropEaN food SafEty autHorIty it is important to highlight that, in the case of a breach of trust of a Management Board member, Efsa has to refer to the appointing authority (council) since the Executive director cannot dismiss a member of the Management Board. recommendation 7 in accordance with article 37 of Efsa’s founding regulation, experts shall declare interests. in 2007, Efsa has adopted a policy, and Guidance and procedures in order to implement this provision. in particular, experts shall declare annually (annual doi) and before the meeting in relation with the agenda (specific doi) and these interests are screened and assessed. the outcome of this assessment is made available in the minutes of Working Groups and panels/scientific committee which are available on Efsa’s website. recommendation 8 training on conflict of interest is compulsory for every Efsa staff member since 2010 (2007 for experts) supported by a dedicated manual and training material on the issue. 
Efsa har tillämpat en upphandlingspolicy 2009. När det gäller gåvor har Efsa i många år tillämpat Europeiska kommissionens ram om etik och integritet och antog en specifik policy i juli 2012. Rekommendation 6 Förfaranden vid förtroendebrott har utformats och tillämpats för följande kategorier: — Samtliga experter (vetenskapliga kommittén, vetenskapliga paneler och arbetsgrupper) (”Genomföran-deakt till policyn för intresseförklaringar – vägledning om intresseförklaringar”, s.
Efsa Management Board Members will receive a dedicated training on Ethics and integrity in october 2012. 
Efsas styrelseledamöter kommer att få en särskild utbildning i etik och integritet under 2012. 98.
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). 
Sedan 2004 har 160 anställda lämnat Efsa och endast två har gått till industrin inom områden som täcks av Efsas ansvarsområde (begränsningar har införts i ett fall).
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) Kriterierna tillämpas sedan 2007 och förbättrades ytterligare 2011 (med den nya policyn för oberoende och vetenskapliga beslutsprocesser samt relaterade genomförandeakter) med hjälp av två självförklarande översiktstabeller som beskriver förenliga och oförenliga intressen.
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) Tillämpas sedan 2012 enligt den nya policyn för oberoende och vetenskapliga beslutsprocesser som Efsas personal omfattas av sedan 2011.
Efsa would welcome such a comprehensive Eu framework. — for staff members: art. 
Efsa skulle välkomna ett sådant övergripande regelverk på EU-nivå.
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). 
IC ok 88 SAMMANFATTNING I. EMA noterar Europeiska revisionsrättens rapport och betonar att myndigheten kommer att förbättra sin hantering av intressekonflikter, liksom man har gjort under de senaste åtta åren, för att uppfylla de rättsliga bestämmelserna om hantering av intressekonflikter som gäller EMA och som fastställts i myndighetens inrättandeförordning, EMA:s regler för god förvaltningssed och i tjänsteföreskrifterna.
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). 
V. EMA anser att man hanterar intressekonflikter på ett tillfredsställande sätt, men erkänner också att det vid tidpunkten för revisionsrättens fältarbete (oktober 2011) fanns ytterligare utrymme för förbättringar. EMA framhåller särskilt följande aspekter: — Trots att det inte har funnits något regelverk i EU för hur intressekonflikter ska hanteras har EMA sedan myndigheten inrättades infört specifika rättsliga bestämmelser som gäller för myndigheten på området och har därmed uppfyllt de rättsliga kraven.
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). 
II. Vid utarbetandet av dessa riktlinjer och förfaranden har man tillämpat ett antal fasta principer som stämmer överens med OECD:s riktlinjer. Även om forskning genomförs av och uppgifter tillhandahålls från läkemedelsindustrin tar EMA hänsyn till all tillgänglig information, även alla andra uppgifter som kommer till myndighetens kännedom.
Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 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. 
Särskild rapport nr 15/2012 – Hantering av intressekonflikter vid utvalda EU‐organ 89 (extern) • 10/26/12, 8:27 AM — Enligt EMA:s riktlinjer om hanteringen av intressekonflikter för ledamöter och experter i de vetenskapliga kommittéerna, måste man vid hanteringen av intressekonflikter finna den bästa jämvikten mellan att säkra att de ledamöter och experter i de vetenskapliga kommittéerna som deltar i EMA:s verksamheter inte har några intressen inom läkemedelsindustrin som skulle kunna påverka deras opartiskhet, samtidigt som man ser till att man har bästa möjliga vetenskapliga expertis.
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. 
Särskild rapport nr 15/2012 – Hantering av intressekonflikter vid utvalda EU‐organ 90 Sedan den 29 september 2011 har EMA dessutom infört en obligatorisk kontroll av intresseförklaringen för ledamöter i vetenskapliga kommittéer innan behörig myndighet kan göra en formell nominering.
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. 
Därutöver erbjuder EMA också alla nominerande myndigheter en förhandskontroll av alla experter, vilken utförs av EMA innan den formella EMA-bedömningen för att medverka i en EMA-verksamhet äger rum. EMA anser emellertid att en ytterligare utökning av denna kontrollverksamhet, enligt revisionsrättens rekommendation, inte är genomförbar med tanke på det nominerings-förfarande som fastställs i EMA:s inrättandeförordning.
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. 
EMA har redan vidtagit flera åtgärder i linje med detta efter revisionsrättens fältarbete i oktober 2011, vilket beskrivs närmare i olika avsnitt i den här rapporten. X. c) ii) EMA noterar revisionsrättens rekommendation och framhåller (vilket revisionsrätten nämner i iakttagelse 92) att detta ligger utanför EMA:s direkta kontroll.
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. 
EMA har vidtagit alla åtgärder som står i myndighetens makt i enlighet med dess befogenheter. EMA:s initiativ, som redan hade införts vid revisionsrättens fältarbete i oktober 2011, är följande: SVAR FRÅN EUROPEISKA LÄKEMEDELSMYNDIGHETEN (1) Ett samförståndsavtal (EMA/150487/2012) undertecknat av respektive nationell behörig myndighet och EMA, som innebär att de nationella behöriga myndigheterna åläggs uttalade skyldigheter att övervaka den vetenskapliga nivån och oberoendet i den utvärdering som utförs av de nationella behöriga myndigheterna för tjänster som ska tillhandahållas EMA.
(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) Den överenskommelse som cheferna för de nationella behöriga myndigheterna, på begäran av EMA, träffade vid deras sammanträde i juli 2011 om ”att EMA:s standarder ska utgöra minimistandarder för intressekonflikter, med nationella avvikelser där så är nödvändigt.”
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. 
Särskild rapport nr 15/2012 – Hantering av intressekonflikter vid utvalda EU‐organ 91 X. c) v) EMA noterar revisionsrättens rekommendation och vill framhålla att följande NYA åtgärder har vidtagits efter revisionsrättens fältarbete i oktober 2011: — Ett förfarande vid trolöshet mot huvudman för ledamöter och experter i vetenskapliga kommittéer har tagits fram och trädde i kraft den 3 april 2012. — Ett förfarande vid trolöshet mot huvudman för styrelseledamöter har tagits fram och trädde i kraft den 7 juni 2012. — Tjänsteföreskrifterna tillämpas för EMA:s personal.