natgillin/translations-raw huggingface dataset:
Notes that the Commission's Internal Audit Service (‘IAS’) carried out a follow-up audit in February 2014 in order to review the implementation of actions stemming from the ‘limited review’ it performed in 2012; notes that the IAS issued a final follow-up report in June 2014, in which it acknowledged progress made by the Institute, closed two recommendations out of the original six and re-rated one from ‘critical’ to ‘very important’; observes that the IAS considered a number of actions as remaining open; calls on the Institute to complete the actions in question without delay and to inform the discharge authority of the outcome of the next IAS evaluation as regards the implementation of those recommendations;
Parlamentet observerar att alla de anslag för 2014 som institutet hade tillgängliga inte behövde utnyttjas i KI-gruppernas affärsplaner, utifrån de bidragsöverenskommelser som ingåtts, och att de anslag som inte användes kommer att återinföras i institutets budgetar för åren 2015–2017, i enlighet med vad som fastställs i institutets finansiella bestämmelser.
Internal controls
Europaparlamentet noterar med oro att enligt revisionsrättens rapport ska KI-grupperna utveckla strategier för finansiell hållbarhet, men att de fortfarande, efter fem verksamhetsår, är helt beroende av finansieringen från institutet och sina partner.
Notes from the Court's report that the Institute gradually improved its financial verification of the KICs’ cost claims; notes with concern, however, that the operational verification of deliverables falls behind and that the KICs’ annual business plans still include an inadequate definition of deliverables, as well as that no clear link between planned deliverables and eligible cost per partner and cost category exists; is concerned about the cases identified by the Court where full amount of the Institute's grant was paid out even if some of the objectives set in the business plan had not been achieved; acknowledges that the Institute’s level of detail in the ex ante technical assessment of the implementation of KIC activities has improved significantly in comparison with previous years and that the Institute put in place a more robust methodology to assess the KICs’ performance based on the reporting;
Parlamentet konstaterar att alla KI-grupper, efter det att institutet antog sina principer för KI-gruppernas finansiella hållbarhet, har gjort sådan hållbarhet till ett av sina prioriterade mål och att verksamheterna ses över därefter, så att de genererar inkomster och så att åtskilliga inkomstflöden skapas.
Acknowledges that the Institute’s internal control standards are largely implemented; notes, however, that further improvements are needed in certain areas such as grant management, procurement and IT; takes note of the fact that the Institute prepared a comprehensive register of audit and other recommendations requiring further action; calls on the Institute to inform the discharge authority on the status of implementation of those actions;
Parlamentet noterar att institutets styrelse antog en uppsättning principer i mars 2015, där man uppgav att det maximala bidrag som institutet kan ge till en KI-grupp ska minskas från upp till 100 % finansiering efter tio år från att en KI-grupp utsetts, till i genomsnitt 80 % för år 11 och därefter minskningar undan för undan: 60 % år 12, 40 % år 13, 20 % år 14 och 10 % år 15.
Ascertains that the Institute’s Internal Audit Capability (‘IAC’) issued 39 recommendations, including one rated as ‘critical’, on the Institute’s conflict of interests policy, as well as 23 recommendations rated as ‘very important’, concerning vacancy management, procurement and management of conflict of interests and sensitive posts; takes note of the fact that the Institute accepted all the IAC recommendations and prepared action plans to implement and monitor them;
Parlamentet uppmanar institutet att överväga en stramare tidsplan för minskningarna.
Performance
Parlamentet noterar vidare att institutet kommer att fortsätta övervaka KI-gruppernas framsteg mot finansiell hållbarhet och vid behov vidta särskilda korrigerande åtgärder.
Notes that in order to reduce costs and promote best practices in the area of public procurement, the Institute participates in a number of inter-institutional procurement procedures of the Commission; takes note of the fact that the Institute and the European Police College signed a Memorandum of Understanding in 2014 given their geographical proximity, with a view of sharing joint procurement procedures;
Europaparlamentet välkomnar att institutet har sett över sina interna förfaranden, flöden och mallar för att fullt ut uppfylla reglerna för offentlig upphandling, med särskild fokus på sund planering och uppskattning av behov.
Notes the Institute's Communications Strategy, its presence on social media and the dissemination of its activities; notes furthermore the Institute’s new dynamic and interactive website launched in 2014 which should keep external stakeholders informed, increase the Institute’s visibility and reach Union citizens more effectively;
Parlamentet konstaterar att institutet rekryterade en ytterligare upphandlingsansvarig under 2015 och genomförde en rad utbildningar om upphandling för sin personal.
Calls on the Institute to enhance its procedures and practices aimed at safeguarding the financial interests of the Union and to actively contribute to a results-oriented discharge process;
Upphandlings- och rekryteringsförfaranden
Refers, for other observations of a cross-cutting nature accompanying its decision on discharge, to its resolution of 28 April 2016 [1] on the performance, financial management and control of the agencies.
Europaparlamentet noterar utifrån revisionsrättens rapport att institutet har haft en mycket hög personalomsättning och brottats med instabilitet på ledningsnivå sedan det inrättades 2009.
Texts adopted, P8_TA(2016)0159 (see page 447 of this Official Journal).
Parlamentet observerar att styrelsen i juni 2014 beslutade att institutets direktör skulle lånas ut på ett långvarigt forskningsuppdrag till Europeiska universitetsinstitutet i Florens de elva månader som återstod av hans mandatperiod.
Resolution (EU) 2016/1535 of the European Parliament
Europaparlamentets resolution (EU) 2016/1535
with observations forming an integral part of the decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2014
med de iakttagelser som utgör en del av beslutet om ansvarsfrihet för genomförandet av budgeten för Europeiska läkemedelsmyndigheten för budgetåret 2014
having regard to its decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2014,
med beaktande av sitt beslut om ansvarsfrihet för genomförandet av budgeten för Europeiska läkemedelsmyndigheten för budgetåret 2014,
having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0114/2016),
med beaktande av betänkandet från budgetkontrollutskottet och yttrandet från utskottet för miljö, folkhälsa och livsmedelssäkerhet (A8-0114/2016), och av följande skäl:
A. whereas, according to its financial statements, the final budget of the European Medicines Agency (‘the Agency’) for the financial year 2014 was EUR 282474000, representing an increase of 12,29 % compared to 2013; whereas 12,53 % of the Agency’s budget derives from the Union budget;
A. Enligt Europeiska läkemedelsmyndighetens (nedan kallad myndigheten) årsredovisning uppgick den slutliga budgeten för budgetåret 2014 till 282474000 EUR, vilket är en ökning med 12,29 % jämfört med 2013.
B. whereas the Court of Auditors (‘the Court’), in its report on the annual accounts of the Agency for the financial year 2014 (‘the Court’s report’), has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2014 are reliable and that the underlying transactions are legal and regular;
12,53 % av myndighetens budget kommer från unionsbudgeten.
Follow-up of 2013 discharge
B. Revisionsrätten har i sin rapport om myndighetens årsredovisning för budgetåret 2014 (nedan kallad revisionsrättens rapport) förklarat att man har uppnått en rimlig säkerhet om att myndighetens räkenskaper för budgetåret 2014 är tillförlitliga och att de underliggande transaktionerna är lagliga och korrekta.
Notes from the Court’s report that regarding one comment made in the Court’s 2012 report and marked as ‘Ongoing’ in the Court’s 2013 report, corrective actions were taken and that comment is now marked in the Court’s report as ‘Completed’;
Uppföljning av ansvarsfrihetsförfarandet för 2013
Comments on the legality and regularity of transactions
Europaparlamentet noterar i revisionsrättens rapport att avseende en kommentar som gjordes i revisionsrättens rapport för 2012 och som markerades som ”pågår” i revisionsrättens rapport för 2013 har korrigerande åtgärder vidtagits och kommentaren är nu markerad som ”har genomförts”.
Notes from the Court’s report that the Agency’s Fee Regulation [1] provides due dates for the collection of fees from applicants and the Agency’s related payments to national competent authorities; notes that these due dates were not respected for most of the transactions audited by the Court; ascertains from the Agency that it has redesigned and streamlined its main operational processes including financial authorisations and fee collections; takes note that the further automation of these processes was planned to be implemented by the Agency by the end of 2015; calls on the Agency to take all further steps needed in order to ensure that its pharmacovigilance responsibilities are fully met and to effectively report to the discharge authority on measures implemented to remedy this issue;
Kommentarer om transaktionernas laglighet och korrekthet
Budget and financial management
Europaparlamentet noterar i revisionsrättens rapport att i myndighetens avgiftsbestämmelser [1] fastställs tidsfrister för när avgifter ska ha samlats in från sökande och för när myndighetens motsvarande betalningar ska göras till nationella behöriga myndigheter.
Recalls that, as stipulated in its financial regulation, budget revenue of the Agency is based on cash received for contributions from the Union, fees for marketing authorisation applications for pharmaceutical products and for post-authorisation activities as well as for various administrative activities;
Dessa tidsfrister iakttogs inte när det gäller merparten av de transaktioner som revisionsrätten granskade.
Notes that budget monitoring efforts during the financial year 2014 resulted in a budget implementation rate of 94,32 %; regrets, however that this represents a decrease of 2,44 % compared with the previous year; notes furthermore that the payment appropriations execution rate was at 82,30 %; regrets that, here again, this represents a decrease of 3,98 %;
Parlamentet erfar från myndigheten att den har omstrukturerat och effektiviserat sina huvudsakliga verksamhetsprocesser, däribland de som gäller finansiella godkännanden och avgiftsinsamling.
Notes that the cancelled appropriations in 2014 were EUR 16054189 (5,68 % of final appropriations); notes furthermore that the Agency is reliant on fee income and that the level of cancelled appropriations does not indicate delays in the implementation of the Agency’s work programme; points out that these cancellations correlate with uncollected revenue appropriations of EUR 10688070 at year-end creating a positive overall out-turn balance of 1,90 % of final appropriations;
Parlamentet noterar att myndigheten hade planerat att ytterligare automatisera dessa processer fram till slutet av 2015.
Commitments and carry-overs
Myndigheten uppmanas att vidta alla ytterligare åtgärder som krävs för att se till att man helt och fullt kan uppfylla sina skyldigheter avseende säkerhetsövervakning, och att till den ansvarsfrihetsbeviljande myndigheten rapportera om vilka åtgärder som vidtagits för att komma till rätta med denna fråga.
Notes with satisfaction the rates of committed appropriations carried over realised by the Agency; notes in particular that the automatic carry-overs to financial year 2015 were at 17,7 % of committed appropriations as well as the absence of non-automatic carry-overs; acknowledges furthermore that the Court’s annual audit found no notable issues with regard to the level of carry-overs in 2014 and commends the Agency for its compliance with the principle of annuality and the timely execution of its budget;
Budgetförvaltning och ekonomisk förvaltning
Calls on the Agency to reduce the level of committed appropriations carried over in the future as far as possible in order to strengthen transparency and accountability;
Europaparlamentet påminner om att myndighetens budgetinkomster enligt budgetförordningen består dels av medel i form av bidrag från unionen, dels av avgifter som tas ut för ansökningar om godkännande för försäljning av läkemedel, för verksamheter efter godkännandet för försäljning och för olika typer av administration.
Transfers
Europaparlamentet noterar att uppföljningen av budgeten under budgetåret 2014 resulterade i ett budgetgenomförande på 94,32 %.
Notes that according to the annual activity report, as well as the Court’s findings, the level and nature of transfers in 2014 remained within the limits of the financial rules; ascertains from the Agency that during 2014 it made nine transfers totalling EUR 29811800 or 11,85 % of final appropriations; notes in particular that the transferred appropriations were primarily used for expenditure on business IT development, rapporteur payments and other adjustments to administrative budget items;
Parlamentet beklagar dock att detta innebär en nedgång med 2,44 % jämfört med föregående år.
Procurement and recruitment procedures
Parlamentet noterar vidare att genomförandenivån för betalningsbemyndiganden låg på 82,30 %.
Takes note from the Agency that, in order to increase the level of human resources allocated to operational tasks, it is further improving its recruitment and resource planning procedures; ascertains from the Court’s Report that in 2014 the Agency concluded an EUR 15000000 framework contract for high-level management consultancy services covering the 2014-2017 period; notes that the objectives and activities to be carried out were not sufficiently specific to justify the procurement decision or the volume of the contract; calls on the Agency therefore, in the interests of transparency and accountability, to ensure that the objectives and activities to be carried out are in fact specified; notes furthermore that the Court found no evidence that the Agency’s Management Board had been consulted on the procurement decision; acknowledges from the Agency that consulting its Management Board in this case was not required by the financial rules;
Även här innebär detta beklagligtvis en minskning, med 3, 98 %.
Asks the Agency to apply strictly the measures pertaining to discretion and exclusion in public procurement, with proper background checks being carried out in every instance, and to apply the exclusion criteria so as to debar companies in the event of any conflict of interest, this being essential to protect the financial interests of the Union;
Europaparlamentet konstaterar att de förfallna anslagen 2014 uppgick till 16054189 EUR (5,68 % av de slutliga anslagen).
Ascertains that the Agency increased transparency in relation to its recruitment procedures by publishing the status of ongoing external procedures and the status of reserve lists on the Agency’s external website, and that it also improved the documentation related to the recruitment procedures;
Parlamentet noterar vidare att myndigheten är beroende av avgifter för sin finansiering, och att nivån på de förfallna anslagen inte tyder på att myndigheten är försenad med genomförandet av sitt arbetsprogram.
Notes that the Advisory Committee on Procurements and Contracts (ACPC), set up in 2012 in order to examine procurement contracts prior to signature on behalf of the Agency, reviewed 73 dossiers during the year 2014; takes note that during 2014, 28 new procurement contracts exceeding EUR 25000 in value were concluded by the Agency following procurement procedures, compared to 30 in 2013 and 43 in 2012;
Dessa förfallna anslag samverkar med ej inkomna planerade intäkter på 10688070 EUR vid årsskiftet, vilket skapade ett positivt resultat totalt på 1,90 % av de slutliga anslagen.
Ascertains that the Agency uses the Early Warning System of the Commission and has access to a database which enables the Agency to check the financial status of potential contractors; notes that any risks identified are alerted to the ACPC and the relevant authorising officer; welcomes the creation of the Central Sourcing Office in December 2014, which is aimed at improving the efficiency and effectiveness of the Agency’s procurement and contract management, whilst ensuring compliance with the relevant Regulation;
Åtaganden och överföringar till efterföljande budgetår
Welcomes that 580 of 599 available posts had been filled by the end of 2014 and that 210 contract agents, seconded national experts and employment agency staff were employed by the Agency; welcomes that the occupation rate has increased compared to 2013; notes that the proportion of contract agents, seconded national experts and employment agency staff has increased compared to 2013; congratulates the Agency for dedicating about 79 % of its human resources to operational tasks, and notes that this represents a slight decrease compared to the situation in 2013;
Europaparlamentet noterar med tillfredsställelse de nivåer på gjorda åtaganden som myndigheten har överfört till efterföljande budgetår.
Prevention and management of conflicts of interests and transparency
Parlamentet noterar särskilt att automatiska överföringar till budgetåret 2015 var 17,7 % av gjorda åtaganden, och att inga icke automatiska överföringar gjordes.
Notes from the Agency the publication of its revised policy on handling of declarations of interests of scientific committee members and experts in November 2014 which entered into force in January 2015; acknowledges that the Agency has defined what are direct and indirect interests and ordered all experts to declare all direct and indirect interests in their annual declaration of interests; notes moreover that restrictions are applied to experts declaring direct or indirect interests which depend on the activity in which they are involved, maintaining the policy distinction between those interests in line with the relevant legislation;
Europaparlamentet konstaterar vidare att revisionsrätten vid sin årliga granskning inte fann några särskilda problem när det gäller andelen överföringar under 2014 och lovordar myndigheten för att den har följt principen om ettårighet och genomfört sin budget i tid.
Encourages the Agency further to raise awareness of the conflict-of-interest policy among its staff, alongside ongoing awareness-raising activities and the inclusion of integrity and transparency as an obligatory item to be discussed during recruitment procedures and performance reviews;
Europaparlamentet uppmanar myndigheten att i framtiden, så långt som möjligt, minska omfattningen på gjorda åtaganden som förs över till påföljande budgetår, så att transparens och redovisningsskyldighet förbättras.
Calls for an overall improvement in the prevention of, and the fight against, corruption through a holistic approach, commencing with better public access to documents and more stringent rules on conflicts of interest, the introduction or strengthening of transparency registers and the provision of sufficient resources for law enforcement measures, and also through improved cooperation among Member States and with relevant third countries;
Överföringar
Calls on the Agency to enhance its procedures and practices aimed at safeguarding the financial interests of the Union and to actively contribute to a results-oriented discharge process;
Europaparlamentet konstaterar att nivån på och typen av överföringar under budgetåret 2014 hölls inom de finansiella bestämmelsernas gränser, både enligt den årliga verksamhetsrapporten och revisionsrättens iakttagelser.
Notes that in December 2014, the Agency’s Management Board adopted an anti-fraud strategy, developed within the framework of the Common Approach on decentralised agencies, adopted in July 2012 by the Parliament, the Council and the Commission; notes furthermore that the scope of the anti-fraud strategy does not encompass ‘regulatory fraud’, which is dealt with through other mechanisms such as inspections; ascertains from the Agency that a possible widening of the strategy’s scope so as to include this type of fraud will be reconsidered;
Parlamentet erfar från myndigheten att den under 2014 gjorde nio överföringar på totalt 29811800 EUR eller 11,85 % av de slutliga anslagen.
Calls on the Agency to pay special attention to the protection of whistle-blowers in the context of the soon-to-be-adopted Directive of the European Parliament and of the Council on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure;
Parlamentet noterar särskilt att de överförda anslagen i första hand användes till företagsutveckling inom it-området, betalning för rapporter och andra justeringar avseende administrativa budgetposter.
Stresses that the Agency should ensure maximum transparency in providing access to clinical reports, and welcomes the Agency’s decision to proactively publish data on clinical trials;
Upphandlings- och rekryteringsförfaranden
Internal controls
Europaparlamentet erfar från myndigheten att den för att öka andelen anställda med operativa arbetsuppgifter ytterligare förbättrar sina rekryterings- och planeringsrutiner.
Takes note that in 2014, the Agency carried out an administrative procedure with respect to its Information, Communication and Technology (ICT) Division; notes that significant weaknesses in management control were reported, implying considerable operational and financial risks to the Agency; notes from the Agency that no considerable financial risks were reported in the administrative enquiry to the Agency’s Executive Director; observes that an action plan to address the issue was established and implemented; calls on the Agency to report to the discharge authority on the effectiveness of the measures taken after they have been evaluated;
Parlamentet ser i revisionsrättens rapport att myndigheten 2014 slöt ett ramkontrakt värt 15000000 EUR för managementkonsulttjänster på hög nivå under perioden 2014-2017.
Observes that the Agency assessed the effectiveness of its key internal control systems during the year 2014; notes that the findings of the review demonstrated the Agency’s internal controls performed well during the year, with no control failure exposing the Agency to the identified risks;
Målen och de aktiviteter som skulle genomföras var inte tillräckligt specifika för att motivera upphandlingsbeslutet eller kontraktets omfattning.
Internal audit
Myndigheten uppmanas därför i transparensens och ansvarighetens intresse att se till att målen och den verksamhet som ska genomföras verkligen specificeras.
Acknowledges that in 2013, the Commission’s Internal Audit Service (IAS) carried out an audit on stakeholder management and communication at the Agency, which showed these areas as being managed effectively; notes furthermore that the IAS submitted its report on consultancy engagement related to IT project management carried out at the end of 2013; observes that this report showed several weaknesses which the Agency set out to resolve by implementing changes in its structure and internal accountability; notes with satisfaction that no critical recommendations were open at year-end, and that the actions on very important recommendations were within the agreed timeline as specified in the Agency’s action plans;
Revisionsrätten fann dessutom inget som tydde på att myndighetens styrelse hade rådfrågats om upphandlingsbeslutet.