natgillin/translations-raw huggingface dataset:
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. 
EMA går igenom samtliga fall och har infört restriktioner för flera anställda vad gäller verksamhet efter anställningen, för att förhindra att intressekonflikter uppstår. En NY åtgärd efter revisionsrättens fältarbete i oktober 2011 är att EMA har utvidgat tillämpningen av artikel 16 i tjänsteföreskrifterna till att även omfatta praktikanter, nationella experter och tillfälligt anställda (1 februari 2012; EMA/78396/2012).
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 uppmärksammar revisionsrätten på att en NY åtgärd har införts sedan revisionsrättens fältarbete i oktober 2011, som innebär att den gemensamma kommittén har avgett ett yttrande, 7/2011 av den 20 oktober 2011, som har meddelats EMA:s personal. I yttrandet erkänns tidigare personals rätt till anställning efter att ha lämnat myndigheten och rätten att använda de kunskaper och erfarenheter som man fått under anställningstiden.
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. Bedömning från fall till fall av personalens verksamhet efter anställning hos EMA har införts. Det finns ingen rättslig grund som låter EMA granska vilken verksamhet som styrelseledamöter eller ledamöter eller experter i vetenskapliga kommittéer ägnar sig åt, då inga av dem är anställda av EMA.
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 anser att man hanterar intressekonflikter på ett tillfredsställande sätt, men erkänner också att det vid tidpunkten för revisionsrättens fältarbete (oktober 2011) fanns utrymme för förbättringar.
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 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 därigenom uppfyllt de rättsliga kraven. Vidare har EMA under de senaste åtta åren fortlöpande övervakat sin hantering av intressekonflikter, analyserat de erfarenheter som gjorts, dragit lärdom av dessa och vidtagit åtgärder när det har varit nödvändigt.
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 visar således att man tar problemet med hanteringen av intressekonflikter på största allvar, att man ser över sina riktlinjer och genomförandet av dessa regelbundet och vidtar åtgärder så snart det behövs. De NYA åtgärderna omfattar följande: — Reviderade riktlinjer för EMA om hanteringen av intressekonflikter för ledamöter och experter i vetenskapliga kommittéer, vilka trädde i kraft den 29 september 2011 och introducerades under revisionsrättens fältarbete i oktober 2011.
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. recommendation 3 EMa notes the court’s recommendation and emphasises (as recognised by the court) that this is outside EMa’s direct control. 
EMA har redan vidtagit flera åtgärder i linje med detta efter revisionsrättens fältarbete i oktober 2011, som beskrivs närmare i olika avsnitt i den här rapporten. Rekommendation 3 EMA noterar revisionsrättens rekommendation och framhåller (vilket revisionsrätten nämner) 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: (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 allt 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: (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’. 
(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.
98 recommendation 4 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. 
98 Rekommendation 4 EMA noterar revisionsrättens rekommendation och framhåller att tydliga och objektiva kriterier redan hade införts av EMA före revisionsrättens fältarbete i oktober 2011 och har förstärkts under de senaste åtta åren, senast 2012. De tillämpas konsekvent vid riskreduceringsåtgärder (begränsad eller nekad medverkan) efter bedömning av intresse-förklaringen.
EMa is updating its code of conduct, last adopted in 2006, to align to all the recently adopted rules and the guidance of the European commission on gifts and hospitality. recommendation 6 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. — article 13 of the staff regulations provides for transfer of EMa staff where spouse employment creates a conflict of interest. at EMa the supplementary sop/EMa/0101 sets out the procedure to be followed 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 administrative enquiries. 
EMA uppdaterar sin uppförandekod, som senast antogs 2006, för att anpassa denna till alla nyligen antagna bestämmelser och Europeiska kommissionens riktlinjer om gåvor och inbjudningar. Rekommendation 6 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. — I artikel 13 i tjänsteföreskrifterna föreskrivs förflyttning av anställda vid EMA i det fall makens sysselsättning medför en intressekonflikt.
EMa also has a policy on reporting improprieties (EMa/11591/2006, 4 January 2006). additional rules on breach of trust for staff would need careful construction not to undermine any of the existing provisions. rEply of tHE EuropEaN MEdICINES agENCy recommendation 7 EMa notes the court’s recommendation but would like to emphasise that at the outset of each meeting Management Board and scientific committees’ members and experts participating at the meeting are requested to declare any conflict of interest in respect of the agenda points, in addition to the evaluation of the declared interests already done by EMa prior to the start of the meeting. such declarations of interests are subsequently minuted. as regards the publication of the minutes, Management Board minutes (including a section on declared conflicts of interests) have already been published for several years. as a new development, the recording of the declared interests has been further fine-tuned since the court’s audit field work in october 2011 in so far as all restricted involvements put in place vis-à-vis the agenda points of the meeting are now recorded. in addition, on 18 July 2012 EMa has started to make public scientific committee meeting minutes (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 all other scientific committees’ minutes before the end of 2013. recommendation 8 EMa has held 18 training sessions for staff on the new rules on handling conflict of interest for staff. in addition, 11 training sessions have been carried out to train managers on the procedures on risk assignment and mitigating actions. all new staff are trained on the conflict of interest policy and the code of conduct during the introduction training that is offered to all new staff, interims, trainees and national experts on secondment. such training is compulsory. articles 11-26 inclusive of the staff regulations and the code of conduct are sent to staff. staff are asked to confirm that they have read and understood the said articles. in addition, EMa at regular intervals informs the scientific committees and other scientific fora on the agency’s handling of conflicts of interests. 
Tillämpningsföreskrifter om administrativa utredningar och disciplinförfaranden (EMA 7/20.8, 8 juni 2012) anger reglerna vid en administrativ utredning. EMA har också riktlinjer för rapportering av oegentligheter (EMA/11591/2006, 4 januari 2006).
EMa applies art 16 of the staff regulations whereby all departing or former staff are required to inform the agency for a two year period of their post-employment activities. 
Artikel 16 i tjänsteföreskrifterna tillämpas av EMA. Det innebär att samtlig avgående eller tidigare anställd personal under två år efter anställningens upphörande måste informera myndigheten om sin sysselsättning.
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. 
EMA går igenom samtliga fall och har infört restriktioner för flera anställda vad gäller verksamhet efter anställningen, för att förhindra att intressekonflikter uppstår.
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 the EMa regarding any post-employment activities whether paid or not for the two year period. recommendation 9 EMa notes the court’s recommendation and wishes to highlight that all EMa staff on departure are reminded in writing of their obligations under the staff regulations and these obligations are extended by analogy to all trainees, national experts on secondment, interims and visiting experts. the obligation (art 17 staff regulations) to respect confidentiality and the obligation to notify EMa about further employment are both stressed. departing staff must acknowledge receipt of this letter and its contents and this confirmation is filed on their personal file. in line with the process and steps of article 16 of the staff regulations all departing or ex staff and in addition extended by decision of the Executive director by analogy to national experts, trainees and interims are required to inform EMa on the details for their paid employment activity after leaving EMa for a period of 2 years. the applications are reviewed by the Joint committee as provided for in article 16 and it issues an opinion. the Joint committee has available to it the details of the previous cases assessed and the restrictions imposed so that consistency in the treatment of cases is applied. in light of this opinion the Executive director issues his decision. in many cases the scope of action of the ex-staff member is restricted and contact with EMa staff is also explicitly restricted. rEply of tHE EuropEaN MEdICINES agENCy Special report No 15/2012 – Management of conflict of interest in selected Eu agencies 
EMA har utvidgat tillämpningen av artikel 16 i tjänsteföreskrifterna till att även omfatta praktikanter, nationella experter och tillfälligt anställda (1 februari 2012; EMA/78396/2012). All avgående personal får en skriftlig påminnelse om sina skyldigheter till sekretess och att man måste ansöka hos EMA om all verksamhet efter anställningen under två års tid, avlönad eller inte. Rekommendation 9 EMA noterar revisionsrättens rekommendation och vill framhålla att samtlig EMA-personal när de slutar vid myndigheten får en skriftlig påminnelse om sina skyldigheter enligt tjänsteföreskrifterna.
European Court of auditors special report no 15/2012 Management of conflict of interest in selected eu agencies luxembourg: publications office of the European union 2012 — 99 pp. — 21 × 29.7 cm ISBN 978-92-9237-876-9 doi:10.2865/21104 
Europeiska revisionsrätten Särskild rapport nr 15/2012 Hantering av intressekonflikter vid utvalda EU‐organ Luxemburg: Europeiska unionens publikationsbyrå 2012 — 99 s. — 21 × 29,7 cm ISBN 978‐92‐9237‐892‐9 doi:10.2865/23289
free publications: how to oBtaIn Eu puBlIcatIons • via EU Bookshop (http://bookshop.europa.eu); • at the European Union’s representations or delegations. 
Gratispublikationer: HUR HITTAR MAN EU:s PUBLIKATIONER? • Genom EU Bookshop (http://bookshop.europa.eu). • Hos Europeiska unionens representationer och delegationer.
You can obtain their contact details on the Internet (http://ec.europa.eu) or by sending a fax to +352 2929-42758. priced publications: • via EU Bookshop (http://bookshop.europa.eu). priced subscriptions (e.g. annual series of the Official Journal of the European Union and reports of cases before the court of justice of the European union): • via one of the sales agents of the Publications Office of the European Union (http://publications.europa.eu/others/agents/index_en.htm). 
Adressuppgifter finns på internet (http://ec.europa.eu/) eller kan fås från fax +352 2929‐42758. Avgiftsbelagda publikationer: • Genom EU Bookshop (http://bookshop.europa.eu). Avgiftsbelagda prenumerationer (t.ex. årsabonnemang på Europeiska unionens officiella tidning och på rättsfallssamlingen från Europeiska unionens domstol) • Genom ett av Europeiska unionens publikationsbyrås försäljningsombud (http://publications.europa.eu/others/agents/index_sv.htm).
EuropEaN Court of audItorS QJ-aB-12-014-EN-C 
EUROPEISKA REVISIONSRÄTTEN QJ-AB-12-014-SV-C
EUROPEAN COURT OF AUDITORS EN THE EFFECTIVENESS OF THE SINGLE AREA PAYMENT SCHEME AS A TRANSITIONAL SYSTEM FOR SUPPORTING FARMERS IN THE NEW MEMBER STATES Special Report No 16 2012 ISSN 1831-0834 
EUROPEISKA REVISIONSRÄTTEN SV ÄNDAMÅLSENLIGHETEN I SYSTEMET FÖR ENHETLIG AREALERSÄTTNING SOM ETT ÖVERGÅNGSSYSTEM TILL STÖD FÖR JORDBRUKARE I DE NYA MEDLEMSSTATERNA Särskild rapport nr 16 2012 ISSN 1831-0990
Special Report No 16 2012 THE EFFECTIVENESS OF THE SINGLE AREA PAYMENT SCHEME AS A TRANSITIONAL SYSTEM FOR SUPPORTING FARMERS IN THE NEW MEMBER STATES (pursuant to Article 287(4), second subparagraph, TFEU) EUROPEAN COURT OF AUDITORS 
Särskild rapport nr 16 2012 ÄNDAMÅLSENLIGHETEN I SYSTEMET FÖR ENHETLIG AREALERSÄTTNING SOM ETT ÖVERGÅNGSSYSTEM TILL STÖD FÖR JORDBRUKARE I DE NYA MEDLEMSSTATERNA (i enlighet med artikel 287.4, andra stycket, EUF‐fördraget) EUROPEISKA REVISIONSRÄTTEN
EUROPEAN COURT OF AUDITORS 12, rue Alcide De Gasperi 1615 Luxembourg LUXEMBOURG Tel. +352 4398-1 Fax +352 4398-46410 E-mail: eca-info@eca.europa.eu Internet: http://eca.europa.eu Special Report No 16 2012 A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server (http://europa.eu). 
EUROPEISKA REVISIONSRÄTTEN 12, rue Alcide De Gasperi 1615 Luxembourg LUXEMBURG Tfn +352 4398-1 Fax +352 4398-46410 E-post: eca-info@eca.europa.eu Internet: http://eca.europa.eu Särskild rapport nr 16 2012 En stor mängd övrig information om Europeiska unionen är tillgänglig på internet via Europa‐servern (http://europa.eu).
Luxembourg: Publications Office of the European Union, 2012 ISBN 978-92-9237-921-6 doi:10.2865/27543 © European Union, 2012 Reproduction is authorised provided the source is acknowledged. Printed in Luxembourg 
Luxemburg: Europeiska unionens publikationsbyrå, 2012 ISBN 978‐92‐9237‐937‐7 doi:10.2865/31078 © Europeiska unionen, 2012 Kopiering tillåten med angivande av källan. Printed in Luxembourg