natgillin/translations-raw huggingface dataset:
Ο EMA σημειώνει την παρατήρηση του Συνεδρίου, αλλά επιθυμεί να υπογραμμίσει την ακόλουθη ΝΕΆ εξέλιξη κατόπιν των επιτόπιων ελέγχων του Συνεδρίου τον Οκτώβριο του 2011: στην αναθεωρημένη πολιτική του για την αντιμετώπιση των συγκρούσεων συμφερόντων των μελών και εμπειρογνωμόνων των επιστημονικών επιτροπών (που τέθηκε σε ισχύ στις 3 Απριλίου 2012) αναφέρεται ότι όταν ένα μέλος επιστημονικού φόρουμ του EMA προτίθεται να απασχοληθεί (κατόπιν πρόσκλησης ή μη) σε φαρμακευτική εταιρία (όπως απασχόληση) κατά τη διάρκεια της θητείας του, το εν λόγω μέλος πρέπει να ενημερώνει άμεσα τον EMA και να απέχει από οιεσδήποτε δραστηριότητες που ενδεχομένως έχουν αντίκτυπο στην ενδιαφερόμενη φαρμακευτική εταιρία. 
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).
86. Το άρθρο 16 του κανονισμού υπηρεσιακής κατάστασης ισχύει για τον EMA, βάσει του οποίου όλα τα απερχόμενα ή παλαιότερα μέλη του προσωπικού υποχρεούνται να ενημερώνουν τον Οργανισμό, για χρονικό διάστημα δύο ετών, για οιαδήποτε απασχόληση μετά την έξοδό τους από την υπηρεσία. 
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.
Ο EMA επανεξετάζει κάθε περίπτωση, έχει δε επιβάλει περιορισμούς σε αρκετά μέλη του προσωπικού για την απασχόλησή τους μετά την έξοδο, ώστε να αποτρέπεται η όποια μελλοντική σύγκρουση συμφερόντων. Μια ΝΕΆ εξέλιξη κατόπιν των επιτόπιων ελέγχων του Συνεδρίου τον Οκτώβριο του 2011 είναι ότι ο EMA επέκτεινε την εφαρμογή του άρθρου 16 του κανονισμού υπηρεσιακής κατάστασης και σε ασκούμενους, εθνικούς εμπειρογνώμονες και προσωρινούς υπαλλήλους (1 Φεβρουαρίου 2012, EMA/78396/2012). 
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.
Ο EMA θέτει υπόψη του Συνεδρίου μια ΝΕΆ εξέλιξη κατόπιν των επιτόπιων ελέγχων του Συνεδρίου τον Οκτώβριο του 2011: η κοινή επιτροπή έχει εκδώσει την υπ’ αριθμό 7/2011 γνωμοδότηση στις 20 Οκτωβρίου 2011 η οποία έχει κοινοποιηθεί στο προσωπικό του EMA. 
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.
Δεν υπάρχει νομική βάση που να δικαιολογεί τον έλεγχο της απασχόλησης μελών του διοικητικού συμβουλίου ή των επιστημονικών επιτροπών ή εμπειρογνωμόνων από τον EMA που δεν απασχολούνται σε αυτόν. ΣΥΜΠΕΡΆΣΜΆΤΆ ΚΆΙ ΣΥΣΤΆΣΕΙΣ 89. 
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. 89.
Ο EMA είναι της άποψης ότι διαχειρίζεται επαρκώς τις συγκρούσεις συμφερόντων, παρόλο που αναγνωρίζει ότι τη χρονική στιγμή που διενεργήθηκαν οι επιτόπιοι έλεγχοι του Συνεδρίου (Οκτώβριος 2011) υπήρχε περιθώριο περαιτέρω βελτίωσης. 
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).
Ο EMA υπογραμμίζει ιδιαίτερα τα ακόλουθα θέματα: — Παρά την απουσία ενός ευρωπαϊκού κανονιστικού πλαισίου για την αντιμετώπιση των συγκρούσεων συμφερόντων, ο EMA, από ιδρύσεώς του, τηρεί τις ειδικές νομικές διατάξεις που εφαρμόζονται στον Οργανισμό στο συγκεκριμένο πεδίο και, ως εκ τούτου, συμμορφώνεται προς τις νομικές απαιτήσεις. 
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.
Συνεπώς, ο EMA αποδεικνύει ότι αντιμετωπίζει με ιδιαίτερη σοβαρότητα το ζήτημα της διαχείρισης των συγκρούσεων συμφερόντων, ότι επανεξετάζει τις πολιτικές του και την εφαρμογή τους σε συνεχή βάση, και ότι αναλαμβάνει διορθωτική δράση όπου απαιτείται. 
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).
Ειδική έκθεση αριθ. 15/2012 – Διαχείριση της σύγκρουσης συμφερόντων σε επιλεγέντες οργανισμούς της ΕΕ 
Special report No 15/2012 – Management of conflict of interest in selected Eu agencies
97 — Στις 9 Ιουνίου 2011 ο EMA θέσπισε κανόνες αναφορικά με τα άρθρα 11α και 13 του κανονισμού υπηρεσιακής κατάστασης που αφορούν την αντιμετώπιση δεδηλωμένων συμφερόντων των εργαζομένων στον EMA (EMA/500408/2011), οι οποίοι τέθηκαν επισήμως σε ισχύ, κατόπιν συμφωνίας της Ευρωπαϊκής Επιτροπής, την 1η Φεβρουαρίου 2012. 
97 — on 9 June 2011 EMa adopted rules relating to articles 11a and 13 of the staff regulations concerning the handling of declared interests of EMa employees (EMa/500408/2011) which officially entered into force, following the agreement of the European commission, on 1 february 2012. these rules were subsequently extended by decision of the Executive director of 1 february 2012 to trainees, national experts on secondment, interims and visiting experts (EMa/78396/2012). recommendation 1 EMa notes the court’s recommendation and would like to emphasise that it is continuously monitoring its handling of conflicts of interests (both from a policy and implementation perspective) and introducing remedial action whenever necessary. documented evidence to support this statement is referred to in various sections of this report. recommendation 2 EMa notes the court’s recommendation but would like to emphasise that, in line with EMa’s founding regulation, scientific committees’ members and experts first need to be nominated after which they need to be included in the European expert list (inclusion is only possible once the nomination form, the declaration of interests and confidentiality undertaking form and the curriculum vitae have been submitted). only when this has been completed they may be appointed for involvement in EMa activities, but prior to such appointment an evaluation by EMa of the individual’s declared conflicts of interests takes place, resulting, where applicable, in restricted or refused involvement, depending on the nature of the declared interest, the timeframe during which such interest occurred and the type of EMa activity. this shows EMa had already acted upon this recommendation prior to the court’s audit field work in october 2011. 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. rEply of tHE EuropEaN MEdICINES agENCy 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.
Οι πρωτοβουλίες που έχει αναλάβει ο EMA, και οι οποίες ήταν ήδη εν εξελίξει κατά τη διενέργεια των επιτόπιων ελέγχων του Συνεδρίου τον Οκτώβριο του 2011, είναι: 1) ένα μνημόνιο συνεννόησης (ΜΣ) (EMA/150487/2012) μεταξύ κάθε εθνικής αρμόδιας αρχής και του EMA με το οποίο θεσπίζονται σαφείς αρμοδιότητες για τις εθνικές αρμόδιες αρχές σε ό,τι αφορά την παρακολούθηση του επιστημονικού επιπέδου και της ανεξαρτησίας της αξιολόγησης που διενεργούν οι εθνικές αρμόδιες αρχές για υπηρεσίες που πρόκειται να παρασχεθούν στον 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: (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.
Πρέπει επίσης να διασφαλίζουν ότι οιοδήποτε αίτημα υποβάλει το Ελεγκτικό Συνέδριο και/ή η Ευρωπαϊκή Υπηρεσία Καταπολέμησης της Απάτης για πρόσβαση σε αρχεία, επιθεώρηση ή έλεγχο αρχείων που αφορούν την αντιμετώπιση συγκρούσεων συμφερόντων μπορεί να εξυπηρετείται εντός εύλογου χρονικού διαστήματος· 2) κατόπιν αιτήματος του EMA, η συμφωνία που συνήψαν οι προϊστάμενοι των υπηρεσιών των εθνικών αρμόδιων αρχών σε συνάντησή τους τον Ιούλιο του 2011 αναφέρει ότι «οι προδιαγραφές του EMA, με οιεσδήποτε εθνικές αποκλίσεις, όπου αυτό είναι απαραίτητο, θα συνιστούν τις ελάχιστες προδιαγραφές για τη σύγκρουση συμφερόντων». 
(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’.
98 Σύσταση 4 Ο EMA σημειώνει τη σύσταση του Συνεδρίου και υπογραμμίζει το γεγονός ότι είχαν ήδη τεθεί σε εφαρμογή από τον EMA σαφή και αντικειμενικά κριτήρια πριν από τους επιτόπιους ελέγχους του Συνεδρίου τον Οκτώβριο του 2011, ότι τα κριτήρια αυτά έχουν ενισχυθεί κατά τα τελευταία οκτώ έτη, πιο πρόσφατα το 2012, και ότι εφαρμόζονται με συνέπεια με τη χρήση μέτρων μετριασμού των κινδύνων (περιορισμός ή απόρριψη συμμετοχής) κατόπιν αξιολόγησης των δεδηλωμένων συμφερόντων. 
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.
Ο EMA αναθεωρεί τον κώδικα δεοντολογίας του, που εγκρίθηκε τελευταία φορά το 2006, ώστε να ευθυγραμμίζεται με τους πρόσφατα εγκριθέντες κανόνες και καθοδήγηση της Ευρωπαϊκής Επιτροπής για τις δωρεές και τη φιλοξενία. 
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.
Ο EMA ήδη διαθέτει πολιτική αναφοράς παρατυπιών (EMA/11591/2006 της 4ης Ιανουαρίου 2006). Κατά την ανάπτυξη επιπρόσθετων κανόνων σχετικά με την κατάχρηση εμπιστοσύνης για το προσωπικό απαιτείται ιδιαίτερη προσοχή ώστε να μην υπονομεύονται οιεσδήποτε υφιστάμενες διατάξεις. ΑΠΑΝΤΗΣΕΙΣ ΤΟΥ ΕΥΡΩΠΑΪΚΟΥ ΟΡΓΑΝΙΣΜΟΥ ΦΑΡΜΑΚΩΝ Σύσταση 7 Ο EMA σημειώνει τη σύσταση του Συνεδρίου και επιθυμεί να υπογραμμίσει ότι στην αρχή κάθε συνεδρίασης ζητείται από το διοικητικό συμβούλιο και από τα μέλη και τους εμπειρογνώμονες των επιστημονικών επιτροπών που συμμετέχουν στη συνεδρίαση να δηλώσουν τυχόν σύγκρουση συμφερόντων σε ό,τι αφορά τα θέματα της ημερήσιας διάταξης, συμπληρωματικά προς την αξιολόγηση των δεδηλωμένων συμφερόντων που έχει ήδη διενεργήσει ο EMA πριν από την έναρξη της συνεδρίασης. 
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.
Ο EMA εφαρμόζει το άρθρο 16 του κανονισμού υπηρεσιακής κατάστασης, βάσει του οποίου όλα τα απερχόμενα ή παλαιότερα μέλη του προσωπικού υποχρεούνται να ενημερώνουν τον Οργανισμό, για χρονικό διάστημα δύο ετών, για οιαδήποτε απασχόληση μετά την έξοδό τους από την υπηρεσία. 
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.
Ο EMA επανεξετάζει κάθε περίπτωση και έχει επιβάλει περιορισμούς σε αρκετά μέλη του προσωπικού αναφορικά με την απασχόλησή τους μετά την έξοδο, ούτως ώστε να αποτρέπεται η όποια μελλοντική σύγκρουση συμφερόντων. 
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.