natgillin/translations-raw huggingface dataset:
31 GD for Sundhed og Fødevaresikkerheds sundhedsmål for den aktuelle programmeringsperiode (2014-2020) omfatter et specifikt mål med relation til beskyttelse af borgerne mod grænseoverskridende sundhedstrusler: at identificere og udvikle sammenhængende tilgange og fremme gennemførelsen heraf for bedre beredskab og koordinering i sundhedsmæssige krisesituationer. 
31 DG Health and Food Safety’s objectives for health in the current programming period (2014-2020) include a specific objective related to the protection of citizens from serious cross-border health threats: to identify and develop coherent approaches and promote their implementation for better preparedness and coordination in health emergencies.
Den dermed forbundne specifikke resultatindikator er »antallet af medlemsstater, der anvender de udviklede fælles tilgange ved udformningen af deres beredskabsplaner«36. 
The related specific result indicator is: ‘Number of Member States integrating the developed common approaches in the design of their preparedness plans [...]’36.
32 For dette specifikke mål og dets indikator fastsatte Kommissionen i sine forvaltningsplaner for 2014 og 2015, at de udviklede fælles tilgange skulle anvendes ved udformningen af beredskabsplaner i fire medlemsstater i 2015, i 14 medlemsstater i 2017 og i samtlige medlemsstater i 2020. 
32 For this specific objective and indicator, the Commission, in its management plans for 2014 and 2015, set the targets at four Member States integrating the developed common approaches in the design of their preparedness plans by 2015, 14 by 2017 and all Member States by 2020.
Målet og indikatoren indgår imidlertid ikke som sådan i afgørelsen, og medlemsstaterne er derfor ikke bundet af dem. 
However, the objective and indicator are not included as such in the decision, meaning that Member States are not bound by them.
Der er heller ikke fastsat kriterier for, hvad der kan betegnes som fælles tilgange ved udformning af beredskabsplaner, og ifølge målet er disse tilgange endnu ikke beskrevet og udviklet. 
It also does not provide criteria on what constitute integrated common approaches in the design of preparedness plans, which, according to the objective would still have to be identified and developed.
Vi konstaterede, at Kommissionen ikke havde videreudviklet konceptet om fælles tilgange sammen med medlemsstaterne efter at have opstillet indikatormålene, og at der ikke var en klar og godkendt metodologi for måling af fremskridt. 
We found that when the Commission set the indicator targets, neither was this concept of common approaches further developed by the Commission in agreement with the Member States, nor was there a clear and agreed approach to measuring progress.
35 Specifikke, målelige, attraktive, realistiske og tidsbestemte. 
35 Specific, measurable, achievable, relevant and time-bound.
36 Samme mål og samme indikator er fastsat i artikel 2 og 3 i forordning (EU) nr. 282/2014 med henblik på resultatmåling af udgifterne vedrørende dette mål. 
36 The same objective and indicator are also provided in Articles 2 and 3 of Regulation (EU) No 282/2014 to measure the performance of the relevant spending under this objective.
Revisionsbemærkninger 22 33 I begyndelsen af 2016 forfinede Kommissionen sin metodologi for måling af fremskridt vedrørende den specifikke indikator og bad ECDC om at analysere dataene fra medlemsstaterne nærmere. 
Audit observations 22 33 Early in 2016, the Commission refined its methodology to measure the progress under the specific indicator and requested ECDC to perform further analysis on the data received from Member States.
ECDC blev bedt om at fastslå antallet af medlemsstater, der havde etableret to af elementerne i IHR-kernekapacite-ten, nemlig interoperabilitet mellem sektorer og driftsstabilitetsplaner. 
ECDC was asked to measure the number of Member States that had in place the elements of IHR core capacity implementation, interoperability arrangements between sectors and business continuity plans.
ECDC konkluderede, at 16 medlemsstater havde erklæret, at de havde etableret disse elementer, og at indikatormålet (14 medlemsstater i 2017) således allerede var opfyldt i 2015. 
ECDC concluded that 16 Member States declared that they had these elements in place and that the indicator for 2015 was therefore ahead of target (i.e. 14 by 2017).
Som det fremgår af punkt 32, kunne vi imidlertid ikke få bekræftet, at denne metodologi var blevet drøftet med og godkendt af Udvalget for Sundhedssikkerhed. 
However, as illustrated in paragraph 32, we could not confirm that this methodology was discussed with and endorsed by the HSC.
34 Vi kunne derfor ikke drage nogen konklusion om, hvad de rapporterede fremskridt betyder for resultaterne, eller fastslå, om alle de definitioner og koncepter, der anvendes i mål, indikatorer og indikatormål, har støtte fra medlemsstaterne. 
34 We were therefore unable to conclude what the reported progress means in terms of performance and whether all definitions and concepts of the objectives, indicators and targets are supported by the Member States.
Dette er særlig vigtigt, fordi en effektiv koordinering af beredskabs-og indsatsplanlægning vedrørende alvorlige grænseoverskridende sundhedstrusler i høj grad afhænger af medlemsstaterne37 og forudsætter, at interessenterne arbejder hen mod de samme mål. 
This is especially important as the effective coordination of preparedness and response planning for serious cross-border threats largely depends on them37, and requires stakeholders to work towards the same objectives.
ECDC’s rolle med hensyn til at sikre et alment beredskab er ikke tilstrækkelig formaliseret 35 ECDC har mandat til at støtte medlemsstaternes og Kommissionens beredskabsak-tiviteter. 
ECDC’s role in relation to generic preparedness is insufficiently formalised 35 ECDC has a mandate to support Member States and the Commission in preparedness activities.
ECDC’s mandat vedrørte oprindelig forebyggelse af og kontrol med sygdomme og er ikke blevet formelt ajourført siden centrets oprettelse, selv om der er sket væsentlige udviklinger på sundhedssikkerhedsområdet, især med ikrafttrædelsen af IHR og vedtagelsen af afgørelsen om alvorlige grænseoverskridende sundhedstrusler. 
ECDC’s mandate was traditionally for disease prevention and control and has not been formally updated since its establishment, despite important health security developments, in particular the entry into force of the IHR and the adoption of the decision on serious cross-border threats to health.
Vi undersøgte derfor, om det mellem Kommissionen og ECDC samt over for ECDC’s interessenter var gjort tilstrækkelig klart, i hvilket omfang ECDC kan yde ekspertbistand inden for alment beredskab, og hvordan det bør planlægge sine aktiviteter og ressourcer i den forbindelse. 
We therefore examined whether it was sufficiently clear between the Commission and ECDC, as well as vis-à-vis ECDC’s stakeholders, to what extent ECDC can provide expertise in the area of generic preparedness and how it should plan its activities and resources for this purpose.
36 ECDC’s oprettelsesforordning fastsætter, at det kan yde videnskabelig og teknisk ekspertbistand til medlemsstaterne, Kommissionen og andre fællesskabsagen-turer ved udarbejdelse, regelmæssig revision og opdatering af beredskabsplaner samt ved udarbejdelse af interventionsstrategier inden for de områder, der henhører under dets kommissorium (dvs. beskyttelse mod infektionssygdomme og trusler af ukendt oprindelse). 
36 ECDC’s founding regulation states that it can provide scientific and technical expertise to the Member States, the Commission and other Community agencies in the development, regular review and updating of preparedness plans, and also in the development of intervention strategies in the fields within its mission (i.e. protection from infectious diseases and threats of unknown origin).
Afgørelsen om alvorlige grænseoverskridende sundhedstrusler giver specifikt ECDC opgaver vedrørende epidemiologisk overvågning samt tidlig varsling og reaktion, men ikke vedrørende støtte til beredskabsplanlægning. 
The decision on serious cross-border threats to health specifically attributes tasks to ECDC for epidemiological surveillance and early warning and response, but not for support on preparedness planning.
37 GD for Sundhed og Fødevaresikkerhed anerkender dette i sin årlige aktivitetsrapport for 2015, hvor det rapporterer om fremskridtene vedrørende dette specifikke mål og dets indikator. 
37 As acknowledged by DG Health and Food Safety in its Annual Activity Report 2015, where it reports on progress for this specific objective and indicator.
Revisionsbemærkninger 23 37 Efter vedtagelsen af afgørelsen om alvorlige grænseoverskridende sundhedstrusler har ECDC arbejdet med nye opgaver38, navnlig på området alment beredskab, for at sikre, at EU har en strategi, der omfatter alle former for risici. 
Audit observations 23 37 Following the adoption of the decision on serious cross-border threats to health, ECDC has been working on new tasks38, especially in the area of generic preparedness, addressing the need for the EU to have an all-hazards approach.
Vi konstaterede imidlertid, at ECDC’s rolle og ansvarsområder vedrørende alment beredskab ikke var formelt defineret og aftalt, hverken ved ajourføring af den relevante lovgivning eller ved f.eks. en skriftlig aftale indgået mellem Kommissionen og ECDC, og godkendt af ECDC’s interessenter. 
However, we found that ECDC’s role and responsibilities in relation to generic preparedness were not formally defined and agreed, either through updates of the relevant legislation or, for example, in a written agreement between the Commission and ECDC, endorsed by ECDC’s stakeholders.
Hvis der ikke er tilstrækkelig formel klarhed om ECDC’s rolle i forbindelse med disse aktiviteter, og om hvordan de passer ind i dets kommissorium, vil ECDC eventuelt ikke kunne forberede sig hensigtsmæssigt på at varetage disse opgaver på lang sigt eller ikke kunne reagere effektivt på anmodninger om bistand. 
If there is insufficient formal clarity on ECDC’s role in these activities and how they fit its mission, the organisation may not be able to properly prepare itself for such tasks in the long term, nor to respond effectively to requests for assistance.
Denne risiko blev allerede til virkelighed i forbindelse med ECDC og WHO’s fælles arbejde med en vejledning om ændring af influenzapandemiplaner, som beskrevet nedenfor. 
The risk stemming from this situation has already materialised in relation to joint work done by ECDC and WHO on a guide for influenza pandemic plan revision, as illustrated below.
38 En af Rådets vigtigste anbefalinger efter influenzapandemien i 2009 var, at der burde udarbejdes en vejledning om beredskabsplaner39. 
38 After the pandemic influenza of 2009 one of the Council’s main recommendations was the adoption of guidance on preparedness plans39.
Over hele Europa begyndte lande at ændre deres pandemiplaner på grundlag af de erfaringer, der var gjort. 
Countries across Europe started revising their pandemic plans based on the lessons learned.
ECDC og WHO-Europe gjorde en betydelig indsats med at arrangere workshopper og gennemgå landenes arbejde. 
ECDC and WHO Europe made a substantial effort in organising workshops and review work.
I 2012 offentliggjorde de et fælles dokument, der beskriver resultaterne af denne indsats40. 
They published a joint document in 2012 listing the outcomes of this exer-cise40.
Derefter arbejdede de på en vejledning om ændring af influenzapandemiplaner41. 
Subsequently, they worked on a ‘Guide for influenza pandemic plan revi-sion’41.
Udkastet til vejledningen var henvendt til alle 53 medlemsstater i WHO’s europæiske region og udarbejdet af eksperter i pandemiberedskabsplanlægning fra forskellige lande og organisationer. 
The drafted guide was addressed to all 53 countries in the WHO European region and was developed by experts in pandemic preparedness planning from various countries and organisations.
39 ECDC’s udgivelse af vejledningen i marts 2014 blev imidlertid stillet i bero af Kommissionen på grund af tvivl om, hvorvidt ECDC havde mandat til at udsende denne type vejledning direkte til medlemsstaterne, og konkluderede, at det er Udvalget for Sundhedssikkerhed, der har mandat til at drøfte spørgsmål om beredskab. 
39 However, the Commission put on hold the publication of the guide by ECDC in March 2014, invoking doubts as regards ECDC’s mandate to issue this type of guidance directly to the Member States and concluding that the HSC is the appropriate and mandated body to discuss matters of preparedness.
Da revisionen fandt sted (to år senere), var tidsplanerne for drøftelsen af vejledningen i Udvalget for Sundhedssikkerhed (eller dets arbejdsgruppe om beredskab) og tidspunktet for dens offentliggørelse ikke kendt. 
At the time of the audit (2 years later) the timelines for discussion of the guide by the HSC (or its preparedness working group) and its publication were not known.
Hvis denne vejledning ikke offentliggøres og promoveres, vil de investerede ressourcer og det udførte arbejde gå til spilde, og den manglende offentliggørelse betyder, at EU-medlemsstaterne og medlemsstaterne i WHO’s europæiske region ikke havde adgang til den, da de ajourførte deres nationale pandemiberedskabsplaner. 
Not publishing and promoting this guide would constitute a lost investment in terms of the resources and efforts engaged for its production and means that EU Member States and WHO Europe countries had no access to it even when efforts were made at national level to update pandemic preparedness plans.
38 En af disse opgaver var ECDC’s bistand til Kommissionen i forbindelse med aggregeringen af data indsendt af medlemsstaterne i medfør af artikel 4 i afgørelse nr. 1082/2013/EU og rapporteringen til Udvalget for Sundhedssikkerhed. 
38 One of these tasks was the assistance provided by ECDC to the Commission in aggregating the data submitted by Member States under Article 4 of Decision No 1082/2013/EU and reporting to the HSC.
39 Rådets konklusioner om 2009-pandemien (H1N1) - en strategisk tilgang, punkt 11, s. 
39 Council conclusions on Pandemic (H1N1) 2009 – a strategic approach, paragraph 11, p.
40 »Key changes to pandemic plans by Member States of the WHO European Region based on lessons learnt from the 2009 pandemic«, WHO Regional Office for Europe og ECDC, 2012. 
40 Key changes to pandemic plans by Member States of the WHO European Region based on lessons learnt from the 2009 pandemic, WHO Regional Office for Europe and ECDC, 2012.
41 »Guide for influenza pandemic plan revision - Applying the lessons learned from the pandemic H1N1(2009): A guide for the Member States of the WHO European Region, European Union and European Economic Area«, udkast fra 2014. 
41 Guide for influenza pandemic plan revision — Applying the lessons learned from the pandemic H1N1(2009): A guide for the Member States of the WHO European Region, European Union and European Economic Area, draft of 2014.
Revisionsbemærkninger 24 42 Rådets konklusioner af 13. september 2010 om erfaringerne fra A(H1N1)-pandemien - Sundhedssikkerhed i Den Europæiske Union. 
Audit observations 24 42 Council conclusions of 13 September 2010 on lessons learned from the A/H1N1 pandemic — health security in the European Union.
ECDC’s hurtige risikovurdering »A case of diphtheria in Spain« af 15. juni 2015, hvor det blev konstateret, at opdagelsen, håndteringen og den folkesundhedsmæssige indsats over for Spaniens første tilfælde af difteri i næsten 30 år havde sat fokus på de beredskabsmæssige udfordringer med hensyn til difteri i Den Europæiske Union. 
43 See ECDC Rapid Risk Assessment ‘A case of diphtheria in Spain’ of 15 June 2015: ‘The detection, management and public health response to the first case of diphtheria in Spain in nearly 30 years has highlighted challenges for preparedness against diphtheria in the European Union.’
Medlemsstaterne er ikke tilstrækkelig interesserede i at sætte fart i fælles indkøb af vaccine mod pandemisk influenza, og der mangler en EU-mekanisme, der kan dække akutte behov for medicinske modforanstaltninger inden for rammerne af afgørelsen om alvorlige grænseoverskridende sundhedstrusler 40 Efter H1N1-influenzapandemien i 2009 opfordrede Rådet Kommissionen til snarest muligt og senest i december 2010 at rapportere om og udarbejde en ordning for fælles indkøb af vacciner og antivirale midler42. 
Insufficient Member State responsiveness to speed up the joint procurement of pandemic influenza vaccine and absence of an EU mechanism to address urgent needs for medical countermeasures within the framework of the decision on serious cross-border threats to health 40 Following the H1N1 influenza pandemic crisis in 2009, the Council42 invited the Commission to report on and develop, as soon as possible and no later than December 2010, a mechanism for joint procurement of vaccines and antiviral medi-cation.
Allerede i 2011 bad Kommissionen medlemsstaterne om at indsende behovsanalyser med henblik på et sådant fælles indkøb. 
Already in 2011, the Commission had invited Member States to provide needs analyses in relation to such a joint procurement procedure.
Der blev imidlertid først etableret et EU-retsgrundlag for fælles indkøb af medicinske modforanstaltninger med vedtagelsen af afgørelsen om alvorlige grænseoverskridende sundhedstrusler i 2013. 
However, it was not until 2013, through the adoption of the decision on serious cross-border threats to health, that there was an EU legal basis for the joint procurement of medical countermeasures.
Kommissionen vedtog aftalen om fælles indkøb den 10. april 2014. 
The Commission adopted the Joint Procurement Agreement on 10 April 2014.
Lande, der har underskrevet aftalen om fælles indkøb, kan deltage i specifikke fælles indkøb af medicinske modforanstaltninger - dog kræver sådanne indkøb deltagelse af mindst fire medlemsstater. 
Countries which have signed the Joint Procurement Agreement can participate in specific joint procurement procedures for medical countermeasures, which require a minimum of four Member States.
41 I februar 2016 færdiggjorde og offentliggjorde Kommissionen udbudsmaterialet til det fælles indkøb af personlige værnemidler, der blev taget initiativ til efter ebolakrisen. 
41 In February 2016, the Commission successfully finalised and published the specifications for the joint procurement of personal protective equipment, initiated in the wake of the Ebola crisis.
Der er også iværksat flere andre specifikke fælles indkøb. 
In addition, several other specific joint procurement procedures have been started.
Forberedelserne til det specifikke fælles indkøb af vaccine mod pandemisk influenza, som Rådet oprindelig opfordrede til i 2010, var imidlertid endnu ikke afsluttet. 
However, preparation of the specific joint procurement procedure for pandemic influenza vaccine, initially requested by the Council in 2010, was still ongoing.
Selv om Kommissionen havde sendt flere anmodninger, havde den i april 2016 kun modtaget behovsanalyser fra fem medlemsstater. 
Despite various requests sent by the Commission only five Member State needs assessments had been received by April 2016.
De fremtidige fremskridt afhænger af, om medlemsstaterne engagerer sig i disse procedurer. 
Future progress depends on the Member States’ commitment to these procedures.
I sin årlige aktivitetsrapport for 2014 og 2015 rapporterede Kommissionen, at målene for fælles indkøb af vaccine mod pandemisk influenza ikke var opfyldt. 
The Commission reported in its Annual Activity Reports for 2014 and 2015 that the targets for joint procurement of pandemic influenza vaccine had not been met.
42 Et kriseinstrument til dækning af akutte behov for medicinske modforanstaltninger vil nødvendigvis skulle være mindre komplekst og tilbyde større hastighed og fleksibilitet end aftalen om fælles indkøb. 
42 An emergency instrument to address urgent needs of medical countermeasures would require less complexity and provide higher speed and greater flexibility than the joint procurement agreement provides.
Da et hospital efter et tilfælde af difteri i Spanien i 2015 havde svært ved at skaffe antitoksin i Europa43, besluttede Udvalget for Sundhedssikkerhed og Kommissionen sig for at undersøge potentielle muligheder for at håndtere sådanne tilfælde i fremtiden. 
Following a case of diphtheria in Spain in 2015, when the treating hospital struggled to get antitoxin in Europe43, the HSC and the Commission decided to look into potential solutions to address such cases in the future.
Udvalget for Sundhedssikkerhed indvilligede i at lade sin arbejdsgruppe om beredskab udvikle standardprocedurer for en hurtig og konsekvent EU-reaktion i sådanne krisesituationer. 
The HSC agreed to task its preparedness working group with the development of standard operating procedures for a rapid and consistent Union response in such emergencies.
I januar 2016 bad Kommissionen medlemsstaterne om at udpege deltagere til Udvalget for Sundhedssikkerheds arbejdsgruppe om beredskab med henblik på udvikling af en standardprocedure for udveksling af medicinske modforanstaltninger. 
In January 2016, the Commission requested Member States to nominate participants in the HSC preparedness group on a standard operating procedure for exchanging medical countermeasures.
Under revisionen kunne vi imidlertid ikke finde bevis for, at der var vedtaget en sådan procedure, eller at der var iværksat noget konkret arbejde (jf. også punkt 46 og 47). 
However, during the audit we could not obtain evidence that the relevant procedure had been agreed or that specific work had been initiated (also see paragraphs 46 and 47).
Revisionsbemærkninger 25 43 På tidspunktet for vores revision konstaterede vi samlet set med hensyn til gennemførelsen af bestemmelserne om fælles indkøb, at det på grund af manglende interesse fra medlemsstaternes side var gået langsomt med at arrangere det fælles indkøb af vaccine mod pandemisk influenza, der blev taget initiativ til efter H1N1-pandemien i 2009, og at der ikke findes en mekanisme på EU-niveau, der kan anvendes til at dække akutte behov for medicinske modforanstaltninger, hvilket potentielt svækker EU’s beredskab mod pandemisk influenza. 
Audit observations 25 43 Overall, as regards the implementation of the joint procurement provisions, we found that progress in organising the joint procurement of pandemic influenza vaccine, initiated after the 2009 H1N1 pandemic, had been slow by the time of our audit due to low Member State responsiveness and that there is no mechanism at EU level to address urgent needs for medical countermeasures, potentially reducing the EU’s preparedness for pandemic influenza.
Strategiske og operationelle udfordringer for det formaliserede Udvalg for Sundhedssikkerhed 44 Udvalget for Sundhedssikkerhed, der blev oprettet ved afgørelsen om alvorlige grænseoverskridende sundhedstrusler, består af repræsentanter for medlemsstaterne og har en repræsentant for Kommissionen som formand (jf. den mere detaljerede beskrivelse af udvalgets rolle og ansvar i bilag II). 
Strategic and operational challenges for the formalised Health Security Committee 44 The decision on serious cross-border threats to health establishes the HSC, composed of representatives from the Member States, and chaired by the Commission (see Annex II for a more detailed description of its role and responsibilities).
45 Samtlige medlemsstater udpegede deres udvalgsmedlemmer. 
45 All Member States have nominated their members of the HSC.
Der blev holdt plenarmøder én gang i 2014 og tre gange i 2015 og afholdt et stort antal audiokonferencer, især om udviklingen i ebolakrisen (jf. tekstboks 4). 
Plenary meetings took place once in 2014 and three times in 2015, as well as a large number of audioconferences, in particular in relation to the evolving Ebola crisis (see Box 4).
Udvalget for Sundhedssikkerhed og ebolaudbruddet Udvalget for Sundhedssikkerhed begyndte at drøfte ebola i marts 2014, efter at Guinea havde underrettet WHO, og ECDC havde udsendt en hurtig risikovurdering. 
The Health Security Committee and the Ebola outbreak Discussions about Ebola started in the HSC in March 2014, after the initial notification of the outbreak by Guinea to WHO and the issuance of a rapid risk assessment by ECDC.