natgillin/translations-raw huggingface dataset:
45 Kommissionens ret til at inspicere medlemsstaternes gennemfżrelse af AMR-overvgningsrammerne er en af de f sikre muligheder, som Kommissionen har for at kontrollere, hvordan medlemsstaterne anvender AMR-relaterede foranstaltninger p veterinžromrdet, og stżtte en bedre gennemfżrelse af disse. 
45 The CommissionŐs right to inspect Member StatesŐ implementation of the AMR monitoring framework is one of the few firm pathways available to the Commission to check how Member States apply AMR veterinary related actions, and support their better implementation.
Kommissionens rapporter er offentligt tilgžngelige37. 
Commission reports are publicly available37.
Mellem 2014 og 2018 undersżgte Kommissionen 14 medlemsstater, herunder tre38 af de fire medlemsstater, vi besżgte i forbindelse med denne revision. 
Between 2014 and 2018, the Commission examined 14 Member States, including three38 of the four Member States we visited in the course of this audit.
Dens besżg havde givet den sikkerhed for, at medlemsstaterne opfyldte deres forpligtelser med hensyn til AMR-relateret overvgning p veterinžromrdet. 
The visits had provided it with assurance that the Member States were meeting their veterinary related AMR monitoring obligations.
Vi konstaterede, at Kommissionens arbejde var af god kvalitet og bidrog til forbedringer af de nationale rammer for overvgning. 
We found that Commission work was of good quality and contributed to improvements in the national monitoring frameworks.
Kommissionen suspenderede sine besżg i slutningen af 2018, da den var af den opfattelse, at de primžre ml med arbejdet var blevet opfyldt, og havde til hensigt at revidere overvgning-og rapporteringsrammen. 
The Commission suspended its visits at the end of 2018, as it considered that the primary objectives of the audit work had been met, and as it planned to revise the monitoring and reporting framework.
36 Technical specifications on harmonised monitoring of antimicrobial resistance in zoonotic and indicator bacteria from food-producing animals and food. 
36 Technical specifications on harmonised monitoring of antimicrobial resistance in zoonotic and indicator bacteria from food-producing animals and food.
37 Kommissionens GD SANTE offentliggżr sine rapporter. 
37 The CommissionŐs DG SANTE publishes its reports.
38 Spanien, Frankrig og Nederlandene. 
38 Spain, France, the Netherlands.
31 Tekstboks 5 Risikoomrder vedrżrende den fremtidige EU-ramme for overvgning og rapportering af antimikrobiel resistens hos zoonotiske og kommensale bakterier Der er sundhedsrisici forbundet med AMR, som stammer fra fżdevarer importeret fra tredjelande, isžr akvakulturprodukter og frisk kżd, men der er ikke tilstržkkelige data til rdighed til at vurdere, hvor alvorlig risikoen er, og om der er behov for sžrlige EU-krav til AMR-overvgningen af disse produkter. 
29 Box 5 Risk areas for the future EU framework on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria There are health risks related with AMR stemming from third country food imports, and in particular aquaculture products and fresh meat, but insufficient data is available to assess the seriousness of the risk and whether specific EU requirements for monitoring AMR in these products is needed.
Vi noterer os, at lignende spżrgsml ogs blev adresseret i 2019 i en videnskabelig rapport fra EFSA36. 
We note that similar issues were also addressed in a 2019 scientific report from EFSA36.
EU's nuvžrende overvgnings-og rapporteringskrav omfatter kvžg, svin og fjerkrž til kżdforbrug, som er de mest almindeligt konsumerede arter i EU som helhed. 
The current EU monitoring and reporting requirements cover cattle, pigs and poultry for meat consumption which are the most commonly consumed species for the EU as a whole.
I visse dele af Europa konsumeres andre arter end dem, der er omfattet af Kommissionens afgżrelse fra 2013, ssom žnder, kaniner, geder og fr, ogs hyppigt. 
In some parts of Europe species other than those covered by the 2013 Commission Decision such as ducks, rabbits, goats and sheep are also frequently consumed.
Visse lande udfżrer mske overvgning af AMR i fżdevarer, der stammer fra disse arter, men EU's ramme kržver det ikke. 
Some countries may perform monitoring of AMR in food originating from these species but this is not required by the EU framework.
EU-budgettet yder betydelig stżtte til AMR-forskning, men dette har endnu ikke resulteret i stżrre gennembrud 46 Forskningen i og udviklingen af nye antimikrobielle stoffer, alternative behandlinger og vacciner er meget kompleks og et vigtigt element i bekžmpelsen af AMR. 
The EU budget provides significant support for AMR research but this has not yet resulted in major breakthroughs 46 The research and development of new antimicrobials, alternative treatments and vaccines is a highly complex and very important element in the fight against AMR.
Stżrstedelen af EU's finansiering af AMR-relaterede foranstaltninger er rettet mod dette. 
This is where the bulk of the EUŐs funding of AMR related actions is directed.
Vi undersżgte, om forskningsindsatsen fulgte en strategisk tilgang, adresserede centrale udfordringer og tilskyndede til bžredygtige resultater. 
We examined whether research efforts followed a strategic approach and addressed key challenges, while encouraging sustainable results.
Kommissionen koordinerer AMR-forskningsindsatsen, men har ikke udfżrt en omfattende evaluering af sin tilgang 47 I sin handlingsplan fra 2017 rapporterede Kommissionen, at den havde brugt over 1,3 milliarder euro p AMR-forskning siden begyndelsen af programmeringsperioden 2000-2006. 
The Commission coordinates AMR research efforts but has not comprehensively evaluated its approach 47 In its 2017 Action Plan the Commission reported that it had spent over Ű1.3 billion on AMR research since the start of the 2000-2006 programming period.
Fžllesforetagendet for IMI tildelte 367 millioner euro til New Drugs for Bad Bugs-programmet (ND4BB). 
In addition, JU IMI allocated Ű367 million to the New Drugs for Bad Bugs Programme (ND4BB).
EU-budgettet finansierer mindst lige s megen forskning i AMR som alle EU's medlemsstater tilsammen. 
The EU budget finances at least as much on AMR research as all EU Member States combined.
Kommissionen er aktiv med hensyn til af koordinere sin F&U-indsats p internationalt plan (f.eks. i G20's knudepunkt for AMR-forskning og -udvikling, den transatlantiske taskforce vedrżrende AMR og JPIAMR). 
The Commission takes an active role in coordinating its R&D efforts internationally (e.g. G20 hub for AMR Research and Development, Transatlantic Taskforce on AMR, JPIAMR).
48 Stżrstedelen af den forskningsindsats, som var finansieret af Kommissionen, vedrżrte forsżg p at udvikle nye antimikrobielle stoffer, alternative behandlinger og vacciner. 
48 The majority of the Commission funded research effort was on the search to develop new antimicrobials, alternative treatments and vaccines.
"skubbe" ider til nye lžgemidler gennem udviklingsfaserne (jf. figur 7 nedenfor) og i sidste ende med at markedsfżre dem. 
This funding uses grant payments, which help ŇpushÓ ideas for new drugs through development phases (see Figure 7 below) and ultimately to their commercialisation.
De kommercielle industrier har i vid udstržkning mistet lysten til at investere i dette omrde (jf. punkt 07), og der er for żjeblikket ingen specifikke żkonomiske "pull"-incitamenter (ssom pržmier for markedsindtržden og modeller for langsigtet forsyningskontinuitet). 
have largely lost their appetite to invest in this area (see paragraph 07); and there are currently no specific ŇpullÓ economic incentives (such as market entry rewards and long term supply continuity models).
Faktisk har forskningsindsatsen ikke resulteret i nye antimikrobielle stoffer i mange r (jf. figur 3). 
Indeed research efforts have so far not lead to new antimicrobials in many years (see Figure 3).
49 Kommissionen har ikke udfżrt en omfattende evaluering af sin stżtte til AMR-forskning, en aktivitet som tegner sig for over 99 % af EU's AMR-budget. 
49 The Commission has not made a comprehensive evaluation of its support to AMR research, an activity that represents over 99 % of the EU budget for AMR.
Dette er vigtigt, eftersom det fremgr af den nylige OECD-undersżgelse (jf. tekstboks 2), at investeringer i forbedret hygiejne, infektionsforebyggelse og antimikrobiel forvaltning inden for sundhedspleje er en omkostningseffektiv anvendelse af offentlige midler og effektivt mindsker den trussel, som AMR udgżr i dag. 
This is important when, as the recent OECD study shows (see Box 2) investments in improved hygiene, infection prevention and antimicrobial stewardship in healthcare are a cost-effective way to spend public money and effectively reduce the threat posed by AMR today.
Endvidere er forskning i AMR i miljżet blevet vigtig med henblik p at tilvejebringe solid dokumentation som grundlag for udformning af fremtidige politikker. 
Furthermore, research into AMR in the environment has become important to provide robust evidence for further policy making.
EU-finansieret forskning har givet nogle positive resultater, men har haft vanskeligt ved at adressere nogle vžsentlige udfordringer 50 Vi rettede vores undersżgelse mod ND4BB-programmet - et banebrydende offentlig-privat initiativ i EU, der skal bekžmpe AMR ved at fremme opdagelse og udvikling af nye behandlinger (jf. bilag II). 
EU funded research produced some positive results, while struggling to address some significant challenges 50 We focused our examination on the ND4BB programme Đ a ground breaking EU public private initiative to combat AMR by boosting the discovery and development of new treatments (see Annex II).
Programmets samlede vžrdi overstiger 650 millioner euro og omfatter 367 millioner euro fra EU-budgettet. 
The total value of the programme exceeds Ű650 million, which includes Ű367 million in EU budget funding.
Figur 7 viser de typiske faser i sżgningen efter nye antimikrobielle stoffer. 
Figure 7 shows the typical stages in the search for new antimicrobials.
33 Figure 7 - Faser i arbejdet med at bringe nye mikrobielle stoffer p markedet Opdagelse Opdagelse og pržklinisk fase 250 Klinisk udvikling Markedsfżring Tidlig opdagelse 5 000-10 000 stoffer 3-6 r Kilde: Revisionsretten p baggrund af oplysninger fra COMBACTE-projekternes forvaltningsenhed (University Medical Centre Utrecht). 
Figure 7 Đ Stages in bringing new antimicrobials to market Push strategies Early discovery 5 000 Đ 10 000 Compounds 3-6 years Discovery Discovery & preclinical 250 Clinical development Commercialisation Pull strategies Market Post-Marketing Surveillance 31 Phase I Phase II 5 Phase III Regulatory review Phase IV Number of patients / Subjects: 20-100 100-500 1 000-5 000 2-3 years 1 NEW DRUG 0.5-2 years indefinite Source: ECA adopted from COMBACTE managing entity (University Medical Centre Utrecht).
51 Vi bemžrkede, at to af de syv projekter, som er omfattet af ND4BB-programmet (TRANSLOCATION og DRIVE AB) blev gennemfżrt inden for de anslede tidsforlżb og budgetter. t program (ENABLE) er p vej til at opfylde eller overg sine ml inden for budgettet, mens de resterende fire projekter (COMBACTE-projekterne og iABC-projektet) oplevede betydelige forsinkelser i anvendelsen af de disponible midler. 
51 We noted that two of the seven projects comprising the ND4BB programme (Translocation and Drive-AB) were executed within the estimated timelines and budgets. One (ENABLE) is on track to meet or exceed its objectives within budget, while the remaining four projects (the Combacte and iABC projects) incurred significant delays in using available funds.
Mere end halvvejs gennem programmets livscyklus ved udgangen af 2018 var gennemfżrelsen betydeligt bagud i forhold til den oprindelige planlžgning, og der var kun indget forpligtelser for en fjerdedel af budgettet for ND4BB, jf. tabel 2. 
As shown in Table 2, more than half way through the lifecycle of the programme at the end of 2018, progress was significantly behind the initial planning and only a quarter of the budget for ND4BB was committed.
Forsinkelserne er ikke overraskende p et omrde, der er s flygtigt og komplekst som opdagelse og udvikling af antibiotika. 
The delays are not surprising in a field as volatile and complex as antibiotic drug discovery and development.
Det er yderst vanskeligt at udżve denne form for aktivitet med de begržnsninger, der er for en traditionel projektdrevet og tilskudsfinansieret tilgang. 
It is extremely difficult to pursue this kind of activity within the constraints of a traditional project-driven and grant-funding approach.
Kilde: Revisionsretten p grundlag af oplysningerne fra fžllesforetagendet for initiativet om innovative lžgemidler (fžllesforetagendet for IMI). 
Source: ECA based on the information provided by Joint Undertaking Innovative Medicines Initiative (JU IMI).
52 Den proces, der ligger mellem opdagelsen af nye lžgemidler og markedsfżringen af nye behandlinger, er meget kompleks og varer typisk op til 15 r (jf. figur 7). 
52 The process from drug discovery to placing new treatments on the market is very complex and typically lasts up to 15 years (see Figure 7).
ENABLE er en platform til opdagelse af antibiotika rettet mod gramnegative bakterier, som er de vanskeligste at behandle med antimikrobielle stoffer. 
ENABLE is a drug discovery platform for antibiotics targeting gram-negative bacteria, which are the most difficult to treat with antimicrobials.
ENABLE finansierer investeringer i specialiseret ekspertise og netvžrkssamarbejde (med deltagelse af den private sektor og den akademiske verden), som er pkržvet i forbindelse med opdagelse af lžgemidler og pržklinisk udvikling. 
ENABLE funds investments in specialist expertise and networking (involving the private sector and academia) needed for drug discovery and pre-clinical development.
En sdan teknisk ekspertise er sžrlig vžrdifuld for SMV'er og akademiske organisationer. 
Such technical expertise is particularly valuable for SMEs and academic organisations.
Platformen żger chancerne for at identificere stoffer, som hurtigt kan gennemg klinisk udvikling. 
This platform increases the chances to identify compounds that can quickly get through clinical development.
P tidspunktet for vores revision var der stadig fem lžgemidler under udvikling i ENABLE - udvalgt fra over 100 interessetilkendegivelser - hvilket overgr det oprindelige ml betydeligt. 
At the time of our audit there were still five drugs in the ENABLE pipeline, from a starting point of over 100 expressions of interest, exceeding the initial target significantly.
Der er imidlertid en risiko for, at bestržbelserne p at udvikle de fem lžgemidler, der stadig er i stżbeskeen, vil aftage, hvis platformen som planlagt lukkes i 2020, og at den kliniske udvikling af lžgemidlerne vil blive forsinket - isžr fordi tre af dem ejes af SMV'er, og t ejes af en akademisk institution. 
However, there is a risk that the efforts to develop the five drugs still in the pipeline will slow down if the platform ends as scheduled in 2020, and that they will delay passing to clinical development - especially as three of these are owned by SMEs and one by an academic institution.
53 COMBACTE-projekterne og iABC-projektet varer op til syv r og sigter mod at stżtte opbyggelsen af kritisk infrastruktur og netvžrk til stżtte for hurtigere opdagelse og klinisk udvikling af nye antimikrobielle stoffer. 
53 The Combacte/iABC projects last up to 7 years, and aimed to support the construction of critical infrastructure and networks to assist the faster discovery and clinical development of new antimicrobials.
P tidspunktet for vores revision var det i vid udstržkning lykkedes projekterne at skabe denne infrastruktur, men der var ingen EU-mekanisme til at finansiere infrastrukturen efter projekternes afslutning. 
By the time of our audit, the projects had largely succeeded in creating this infrastructure, but there was no EU mechanism to finance the infrastructure after the projectsŐ end.
54 Projekterne for klinisk udvikling - COMBACTE-NET og COMBACTE-MAGNET - tester nye lovende produkter, og opbygningen af netvžrksinfrastrukturen har givet vžrdifulde resultater. 
54 The Combacte-NET and Magnet clinical development projects were trialling promising new products, and the construction of the network infrastructure has yielded valuable results.
Disse projekter letter kapacitetsopbygning vedrżrende kliniske forsżg og udvikling i lande, hvor AMR-niveauet er hżjt. 
These projects facilitate capacity building for clinical trials and development in countries that face high levels of AMR.
Projekterne tiltržkker ogs interesse fra ikke-europžiske selskaber inden for udvikling af antimikrobielle stoffer, og et samarbejde fandt sted med et lignende amerikansk forskningsprojekt. 
The projects are also attracting the interest of non-European companies in the field of antimicrobial development, and there was collaboration with a similar American research project.
EU-budgettets finansiering af disse projekter skal efter planen ophżre i 2021. 
EU budget funding for these projects is scheduled to end in 2021.
55 Kommissionen gav i 2018 COMBACTE-projekternes forvaltningsenhed et tilskud til udvikling af en forretningsmodel for et nyt net for kliniske forsżg (ECRAID-planen) med henblik p at sammenlžgge det eksisterende COMBACTE-net med et net for kliniske forsżg, udviklet til nye smitsomme sygdomme. 
55 The Commission awarded a grant in 2018 to the Managing Entity of the Combacte projects to develop a business model for a new clinical trials network (ECRAID - plan), to merge the existing ŇCombacteÓ network with a clinical trials network developed for emerging infectious diseases.
ECRAID-planen forventes at starte i 2021. 
ECRAID - plan is scheduled to start in 2021.
Da vi udfżrte vores revision, var der ikke fastsat nogen proces for bevarelse af infrastrukturer udviklet under COMBACTE. 
At the time of our audit there was no agreed process to maintain the infrastructures developed under Combacte.
56 I EU's One Health-handlingsplan vedrżrende AMR fastlagde Kommissionen mlet om at stżtte SMV'er i deres forsknings-og udviklingsindsats. 
56 In the EU One Health Action Plan on AMR, the Commission set the objective to support SMEs in their research and development efforts.
SMV'ernes rolle i opdagelsen af antimikrobielle stoffer bliver stadigt stżrre, isžr fordi store medicinalfirmaer har trukket sig tilbage fra denne forskning (jf. punkt 07). 
The role of SMEŐs in the discovery of antimicrobials is increasing, particularly given the withdrawal of large pharmaceutical companies from such research (see paragraph 07).
5 % af midlerne fra ND4BL-programmet var blevet anvendt til SMV'er, hovedsagelig under ENABLE-projektet for opdagelse af lžgemidler. 
Only about 5 % of funding from the ND4BB programme had been used for SMEs, mostly under the Enable project for drug discovery.
57 EU's One Health-handlingsplan fastlžgger en strategi for Kommissionens stżtte-og forskningsaktiviteter. 
57 The EU One Health Action Plan provides a strategy for the CommissionŐs support and research activities.
Den omfatter planlagte aktiviteter med henblik p at forbedre kendskabet til opdagelse, infektionskontrol og overvgning, udvikle nye behandlingsmetoder og alternativer og udvikle nye forebyggende vacciner. 
It includes planned actions to improve knowledge on detection, infection control and surveillance; develop new therapeutics and alternatives; and develop new preventive vaccines.
Handlingsplanen adresserer imidlertid ikke alle de specifikke udfordringer i forbindelse med AMR-forskning, navnlig: - de lange tidsforlżb og udfordringer, som er forbundet med opdagelse og udvikling af nye antibiotika - hvordan langsigtede forskningsprioriteter kan integreres, og aktiviteter kan opretholdes over flere programmeringsperioder - metoderne for samarbejde med alle relevante interessenter (akademikere, SMV'er, medicinalindustrien, internationale finansierings-og koordineringsinitiativer). 
However the Action Plan does not address all of the specific challenges for AMR research, notably: Ń the long timelines and challenges involved in the discovery and development of new antibiotics; 33
Kommissionens initiativer har endnu ikke fundet en lżsning p markedssvigtene inden for forskning i og udvikling af antimikrobielle stoffer 58 Medicinalfirmaer har besluttet at tržkke visse antimikrobielle stoffer, der stadig virker39, tilbage fra markedet i visse medlemsstater, f.eks. en fżrstevalgsbehandling til samfundserhvervet lungebetžndelse og en anbefalet behandling til visse urinvejsinfektioner. 
Commission initiatives have not yet resolved the market failures in antimicrobial research and development 58 Pharmaceutical companies have decided to withdraw from the market of certain Member States some antimicrobials that continue to work39, such as a first-line treatment option for community-acquired pneumonia, and a recommended treatment for certain urinary tract infections.
Kommissionen har ikke et udtrykkeligt mandat til at foresl initiativer med henblik p at undg eller forsinke, at eksisterende antimikrobielle stoffer tilbagetržkkes fra markedet. 
The Commission does not have an explicit mandate to propose initiatives to avoid or slow down the withdrawal of existing antimicrobials from the market.
59 Kommissionen havde i sin One Health-handlingsplan vedrżrende antimikrobiel resistens fra 2017 plagt sig selv at stżtte forskning i udvikling af nye żkonomiske modeller, der kan bruges til at stżtte udviklingen af nye antimikrobielle stoffer. 
59 In its 2017 EU One Health Action Plan on antimicrobial resistance, the Commission had tasked itself with supporting research into the development of new economic models to support the development of new antimicrobials.
60 Vi konstaterede, at fžllesforetagendet for IMI sammen med sine partnere samlet set var i stand til at fastholde den forventede grad af offentlig-privat samarbejde i ND4BB-programmet (jf. tabel 2), p trods af at medicinalindustrien generelt havde trukket sig tilbage fra antimikrobiel forskning. 
60 We found that despite the general withdrawal of pharmaceutical industries from antimicrobial research, JU IMI together with its partners was overall able to maintain the expected level of public-private collaboration in the ND4BB programme (see Table 2).
Dette er opmuntrende, men der er bekymring over, at medicinalfirmaerne ikke gives tilstržkkelige kommercielle incitamenter til at investere i dette omrde. 
While this is encouraging, there are concerns about the insufficient commercial incentives for pharmaceutical companies to invest in this field.
61 DRIVE AB-projektet udarbejdede i marts 2018 en rapport med anbefalinger til styrkelse af investeringsklimaet og udviklingen af nye antimikrobielle stoffer. 
61 The Drive-AB project produced a report in March 2018 making recommendations for strengthening the investment climate and pipeline for new antimicrobials.
Rapporten bekržftede, at markedet for udvikling af nye antimikrobielle stoffer generelt ikke var kommercielt attraktivt. 
The report confirmed that the market for developing new antimicrobials was in general not commercially attractive.
Den forklarede, hvordan push-incitamenter ssom tilskudsbetalinger kunne džkke F&U-omkostninger, men ikke gjorde det generelle marked mere attraktivt. 
It explained how push incentives such as grants may pay for the costs of R&D but did not improve the attractiveness of the overall market.
Rapporten konkluderede, at der var brug for pull-mekanismer. 
The report concluded that pull mechanisms were needed.
1 milliard euro ville vžre nżdvendig, hvis en markeds-pull-mekanisme skulle bringe t nyskabende antibiotikum p markedet. 
It estimated that approximately Ű1 billion would be necessary for a market pull mechanism to successfully bring one first-of-a-kind new antibiotic to the market.