natgillin/translations-raw huggingface dataset:
Indeed research efforts have so far not lead to new antimicrobials in many years (see Figure 3). 
Dosedanja raziskovalna prizadevanja dejansko že mnogo let niso privedla do novih antimikrobikov (glej sliko 3).
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. 
49 Komisija ni izvedla celovite ocene svoje podpore raziskavam na področju protimikrobne odpornosti, ki jim je dodeljenih več kot 99 % proračuna EU, namenjenega protimikrobni odpornosti.
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. 
To je pomembno, saj je nedavna študija organizacije OECD pokazala (glej okvir 2), da so naložbe v boljšo higieno, preprečevanje okužb in usmerjanje porabe antimikrobikov v zdravstvu stroškovno učinkovit način porabe javnih sredstev ter uspešno zmanjšujejo nevarnost, ki jo danes predstavlja protimikrobna odpornost.
Furthermore, research into AMR in the environment has become important to provide robust evidence for further policy making. 
Poleg tega so postale raziskave na področju protimikrobne odpornosti v okolju pomembne za zagotovitev zanesljivih dokazov za nadaljnje oblikovanje politik.
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). 
Raziskave, ki jih je financirala EU, so imele nekaj pozitivnih rezultatov, obravnava nekaterih izzivov pa je bila težka naloga 50 Preiskava Sodišča je bila osredotočena na prelomno javno-zasebno pobudo EU „nova zdravila za slabe bacile”, namenjeno boju zoper protimikrobno odpornost s spodbujanjem odkrivanja in razvoja novih zdravljenj (glej Prilogo II).
The total value of the programme exceeds Ű650 million, which includes Ű367 million in EU budget funding. 
Skupna vrednost programa presega 650 milijonov EUR, v kar je zajetih 367 milijonov EUR proračunskih sredstev EU.
Figure 7 shows the typical stages in the search for new antimicrobials. 
Na sliki 7 so prikazane značilne faze pri odkrivanju novih antimikrobikov.
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). Pre-discovery 
Slika 7 – Faze dajanja novih antimikrobikov na trg 32 strategije potiska Odkrivanje Odkrivanje & predklinična faza 250 Klinični razvoj Trženje Faza IV strategije pritegovanja Trg Nadzor po pridobitvi dovoljenja za promet Zgodnje odkrivanje 5 000 – 10 000 sestavin 3–6 let Faza I Faza II 5 Faza III Regulativni pregled število bolnikov/primerov: 20–100 100–500 1 000–5 000 2–3 leta 1 NOVO ZDRAVILO 0,5–2 leti nedoločeno Vir: ECA, prilagojeno po podatkih subjekta, ki upravlja projekt COMBACTE (Univerzitetni zdravstveni center Utrecht) 51 Sodišče je ugotovilo, da sta bila dva od sedmih projektov, zajetih v programu „nova zdravila za slabe bacile” (Translocation in Drive-AB), izvedena v predvidenih časovnih okvirih in s predvidenim proračunom.
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. 
En projekt (ENABLE) je na dobri poti, da doseže ali preseže svoje cilje v okviru proračuna, medtem ko so pri preostalih štirih (projektih COMBACTE in iABC) nastale velike zamude pri uporabi razpoložljivih sredstev.
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. 
Kot je navedeno v tabeli 2, je bil na polovici življenjskega cikla tega programa konec leta 2018 napredek znatno počasnejši od sprva načrtovanega in prevzeta je bila samo četrtina proračunskih obveznosti zanj.
The delays are not surprising in a field as volatile and complex as antibiotic drug discovery and development. 
Zamude niso presenetljive, saj sta za področje odkrivanja in razvoja antibiotikov značilna volatilnost in kompleksnost.
It is extremely difficult to pursue this kind of activity within the constraints of a traditional project-driven and grant-funding approach. 
Tovrstne dejavnosti je izjemno težko izvajati ob omejitvah tradicionalnega, projektno usmerjenega in z nepovratnimi sredstvi financiranega pristopa. pred odkrivanjem
Table 2 Đ Progress on the ND4BB programme is delayed 32 Project name Total duration Months Project START date Project END date % time elapsed to 31/12/2018 IMI total contribution (million euro) Total Committed (budgeted) EFPIA in-kind (million euro) Total IMI costs validated by 31/12/2018 (million euro) % of IMI total paid by 31/12/2018 Total EFPIA in kind contribution validated by 31/12/2018 (million euro) % of EFPIA total in-kind contributions valided by 31/12/2018 COMBACTE-NET 98 01/02/2013 28/02/2021 73 % 110 110 28 25 % 22 20 % TRANSLOCATION 66 01/01/2013 30/06/2018 100 % 16 8 16 100 % 7 88 % ENABLE 72 01/02/2014 31/01/2020 82 % 59 23 19 32 % 16 70 % DRIVE-AB 39 01/10/2014 31/12/2017 100 % 6 3 6 100 % 2 67 % Combacte-CARE 60 01/03/2015 29/02/2020 77 % 24 60 5 21 % 15 25 % Combacte-MAGNET 84 01/01/2015 31/12/2021 57 % 75 92 13 17 % 11 12 % iABC Programme 77 01/08/2015 31/12/2021 53 % 24 30 7 29 % 8 27 % Sub total 314 326 94 81 Other projects (mainly under Horizon 2020) 53 34 0 0 Total ND4BB 367 360 94 26 % 81 23 % Note: EFPIA: European Federation of Pharmaceutical Industries and Associations. 
12. 2018 (v milijonih EUR) Delež skupnih stvarnih prispevkov federacije EFPIA, potrjen do 13. 2018, v odstotkih COMBACTE-NET 98 01/02/2013 28/02/2021 73 % 110 110 28 25 % 22 20 % TRANSLOCATION 66 01/01/2013 30/06/2018 100 % 16 8 16 100 % 7 88 % ENABLE 72 01/02/2014 31/01/2020 82 % 59 23 19 32 % 16 70 % DRIVE-AB 39 01/10/2014 31/12/2017 100 % 6 3 6 100 % 2 67 % Combacte-CARE 60 01/03/2015 29/02/2020 77 % 24 60 5 21 % 15 25 % Combacte-MAGNET 84 01/01/2015 31/12/2021 57 % 75 92 13 17 % 11 12 % iABC Programme 77 01/08/2015 31/12/2021 53 % 24 30 7 29 % 8 27 % Vmesni seštevek 314 326 94 81 Drugi projekti (večinoma v okviru programa Obzorje 2020) 53 34 0 0 Skupaj za program „nova zdravila za slabe bacile“ 367 360 94 26 % 81 23 % Opomba: EFPIA: Evropska federacija farmacevtske industrije in združenj Vir: Evropsko računsko sodišče na podlagi informacij, ki jih je zagotovilo Skupno podjetje IMI 52 Proces od odkritja zdravila do dajanja novih zdravljenj na trg je zelo kompleksen in običajno traja do 15 let (glej sliko 7).
ENABLE is a drug discovery platform for antibiotics targeting gram-negative bacteria, which are the most difficult to treat with antimicrobials. 
Projekt ENABLE je platforma, namenjena odkrivanju antibiotikov za uničevanje gramnegativnih bakterij, ki jih je z antimikrobiki najtežje zdraviti.
ENABLE funds investments in specialist expertise and networking (involving the private sector and academia) needed for drug discovery and pre-clinical development. 
Iz projekta ENABLE se financirajo naložbe v specialistično strokovno znanje in povezovanje v mreže (pri čemer sodelujejo zasebni sektor in akademiki), ki sta potrebna za odkrivanje in predklinični razvoj zdravil.
Such technical expertise is particularly valuable for SMEs and academic organisations. 
To tehnično strokovno znanje je zlasti dragoceno za mala in srednja podjetja (v nadaljnjem besedilu: MSP) ter akademske organizacije.
This platform increases the chances to identify compounds that can quickly get through clinical development. 
S to platformo se povečajo možnosti za opredelitev sestavin, ki lahko hitro napredujejo skozi fazo kliničnega razvoja.
Its aim was to lead to one product which could pass to clinical trials. 
Njen cilj je bil privesti do enega proizvoda, ki bi lahko prešel na klinično preskušanje.
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. 
V času revizije Sodišča je v okviru projekta ENABLE še vedno v postopku pet zdravil v primerjavi z začetnimi skoraj 100 prijavami interesa, s čimer je bil začetni cilj znatno presežen.
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. 
Vendar pa obstaja tveganje, da se bodo prizadevanja za razvoj petih zdravil, za katere postopek še poteka, upočasnila, če se bo platforma končala leta 2020, kot je bilo načrtovano, in da bo prišlo do zakasnitve pri prehodu v fazo kliničnega razvoja, zlasti zato, ker so tri zdravila v lasti MSP, eno pa akademske institucije.
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. 
53 Projekti Combacte/iABC trajajo do sedem let, njihov namen pa je podpreti vzpostavljanje kritične infrastrukture in omrežij, ki bi pripomogli k hitrejšemu odkrivanju in kliničnemu razvoju novih antimikrobikov.
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. 
Vzpostavitev te infrastrukture v okviru projektov je bila do časa revizije Sodišča pretežno uspešna, vendar po izteku projektov ni bilo mehanizma EU za njeno financiranje.
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. 
54 V projektih kliničnega razvoja Combacte-NET in Magnet so bili preskušani novi obetavni proizvodi in izgradnja omrežne infrastrukture je prinesla dragocene rezultate.
These projects facilitate capacity building for clinical trials and development in countries that face high levels of AMR. 
Ti projekti olajšujejo gradnjo zmogljivosti za klinična preskušanja in razvoj v državah, ki
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. 
Projekti vzbujajo tudi zanimanje neevropskih podjetij, ki delujejo na področju razvoja antimikrobikov, in vzpostavilo se je sodelovanje s podobnim ameriškim raziskovalnim projektom.
EU budget funding for these projects is scheduled to end in 2021. 
Financiranje iz proračuna EU za te projekte se bo predvidoma izteklo konec leta 2021.
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. 
55 Komisija je leta 2018 subjektu, ki upravlja projekte Combacte, dodelila nepovratna sredstva za razvoj poslovnega modela nove mreže za klinična preskušanja (načrt ECRAID), ki bi združila obstoječo mrežo Combacte z mrežo za klinična preskušanja, namenjeno porajajočim se nalezljivim boleznim.
ECRAID - plan is scheduled to start in 2021. 
Načrt ECRAID naj bi se začel izvajati leta 2021.
At the time of our audit there was no agreed process to maintain the infrastructures developed under Combacte. 
V času revizije Sodišča ni bilo dogovorjenega postopka za vzdrževanje infrastrukture, ki je bila vzpostavljena v okviru projektov Combacte.
56 In the EU One Health Action Plan on AMR, the Commission set the objective to support SMEs in their research and development efforts. 
56 Komisija si je v akcijskem načrtu EU „eno zdravje” zoper protimikrobno odpornost zastavila cilj podpreti MSP pri njihovih raziskovalnih in razvojnih prizadevanjih.
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). 
Vloga MSP pri odkrivanju antimikrobikov se povečuje, zlasti zaradi umika velikih farmacevtskih podjetij iz raziskav na tem področju (glej odstavek 07).
Only about 5 % of funding from the ND4BB programme had been used for SMEs, mostly under the Enable project for drug discovery. 
Samo približno 5 % sredstev iz programa „nova zdravila za slabe bacile” je bilo porabljenih za MSP, večinoma v okviru projekta Enable za odkrivanje zdravil.
57 The EU One Health Action Plan provides a strategy for the CommissionŐs support and research activities. 
57 Akcijski načrt EU „eno zdravje” zagotavlja strategijo za podporo in raziskovalne dejavnosti Komisije.
It includes planned actions to improve knowledge on detection, infection control and surveillance; develop new therapeutics and alternatives; and develop new preventive vaccines. 
Vanj so vključeni načrtovani ukrepi za izboljšanje znanja o odkrivanju in obvladovanju okužb ter nadzoru nad njimi, razvoj novih in alternativnih oblik zdravljenja ter razvoj novih preventivnih cepiv.
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 
Vendar v akcijskem načrtu niso obravnavani vsi posebni izzivi za raziskave na področju protimikrobne odpornosti, zlasti: — dolgi časovni načrti in izzivi, povezani z odkrivanjem in razvojem novih antibiotikov, — kako vključiti dolgoročne raziskovalne prioritete in vzdrževati dejavnosti v vseh programskih obdobjih, — načini sodelovanja z vsemi relevantnimi deležniki (akademiki, MSP, farmacevtsko industrijo, mednarodnim financiranjem in usklajevalnimi pobudami).
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. 
Pobude Komisije doslej še niso odpravile nedelovanja trga pri raziskavah in razvoju antimikrobikov 58 Farmacevtska podjetja so se odločila, da s trga nekaterih držav članic umaknejo nekatere še učinkovite antimikrobike39, kot sta možnost zdravljenja prve izbire za zunajbolnišnično pridobljeno pljučnico in priporočeno zdravljenje za nekatere okužbe sečil.
The Commission does not have an explicit mandate to propose initiatives to avoid or slow down the withdrawal of existing antimicrobials from the market. 
Komisija nima izrecnih pooblastil, da bi predlagala pobude za preprečevanje ali upočasnitev umika obstoječih antimikrobikov s trga.
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. 
59 Komisija si je v svojem akcijskem načrtu EU „eno zdravje” zoper protimikrobno odpornost iz leta 2017 zadala nalogo, da bo podpirala raziskave na področju razvoja novih ekonomskih modelov za podporo razvoju novih antimikrobikov.
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). 
60 Sodišče je ugotovilo, da je Skupno podjetje IMI skupaj s partnerji kljub splošnemu umiku farmacevtske industrije iz raziskav na področju antimikrobikov zmoglo ohraniti pričakovano raven javno-zasebnega sodelovanja v programu „nova zdravila za slabe bacile” (glej tabelo 2).
While this is encouraging, there are concerns about the insufficient commercial incentives for pharmaceutical companies to invest in this field. 
To je sicer spodbudno, vendar se pojavljajo pomisleki glede nezadostnih komercialnih spodbud za naložbe farmacevtskih podjetij v to področje.
61 The Drive-AB project produced a report in March 2018 making recommendations for strengthening the investment climate and pipeline for new antimicrobials. 
61 V okviru projekta Drive-AB je bilo marca 2018 objavljeno poročilo, v katerem so bila dana priporočila za poživitev naložbenega okolja in postopkov za nove antimikrobike.
The report confirmed that the market for developing new antimicrobials was in general not commercially attractive. 
V poročilu je potrjeno, da trg za razvoj novih antimikrobikov na splošno ni poslovno privlačen.
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. 
V njem je bilo pojasnjeno, kako je bilo mogoče s spodbudami potiska, kakršne so nepovratna sredstva, kriti stroške raziskav in razvoja, vendar te niso izboljšale privlačnosti celotnega trga.
The report concluded that pull mechanisms were needed. 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. 
V poročilu je bilo ugotovljeno, da so potrebni mehanizmi za pritegnitev: po ocenah iz poročila bi bilo treba približno 1 milijardo EUR nameniti tržnemu mehanizmu za pritegnitev, da bi se uspešno uvedlo nov antibiotik še neodkrite vrste na trg.
The Commission has disseminated the results of the Drive-AB study to Member States, and in consultation with international partners (see paragraph 47) was considering next steps to boost development of new 39 See ŇTackling DrugĐResistant Infections Globally: Final report and recommendationsÓ, 2016, by the UK Review on AMR; Unavailability of old antibiotics threatens effective treatments for common bacterial infectionsÓ, Lancet Volume 18 2018. 
Komisija je rezultate študije v okviru projekta Drive-AB posredovala državam članicam in je v posvetovanju z mednarodnimi partnerji (glej odstavek 47) pretehtavala naslednje korake za spodbuditev razvoja novih antimikrobikov.
By the time of our audit the Commission had not decided on specific initiatives to promote pull mechanisms. 
Komisija se do revizije še ni odločila o specifičnih pobudah, s katerimi bi se spodbudili mehanizmi za pritegnitev.
35 Conclusions and recommendations 62 Antimicrobial resistance (AMR) happens when microbes develop resistance against medicines that previously worked. 
35 Zaključki in priporočila 62 Protimikrobna odpornost se pojavi, ko mikrobi razvijejo odpornost proti zdravilom, ki so pred tem učinkovala.
It is a serious and growing threat to global and European health. 
Gre za resno in vedno večjo grožnjo za zdravje v svetu in Evropi.
An estimated 33 000 people already die each year in the EU / EEA from infections caused by drug resistant bacteria, leading to additional costs of Ű1.5 billion. 
Po ocenah zaradi okužb, ki jih povzročajo bakterije, odporne na zdravila, v EU/EGS vsako leto umre že približno 33 000 ljudi, kar povzroča dodatne stroške v višini 1,5 milijarde EUR.
The EU follows the ŇOne HealthÓ approach to AMR, with an integrated approach to human health, animal health and the environment. 
EU uporablja celovit pristop k protimikrobni odpornosti po načelu „eno zdravje” k zdravju ljudi, zdravju živali in okolju.
63 Human health is a Member State competence. 
63 Zdravje ljudi je v pristojnosti držav članic.
The CommissionŐs role is to complement and support Member StatesŐ actions. 
Vloga Komisije bi morala biti dopolnjevanje in podpora ukrepov držav članic.
There are EU rules on monitoring the consumption of antimicrobials and on the surveillance of resistant infections. 
Obstajajo pravila EU o spremljanju uporabe antimikrobikov in o nadzoru nad odpornimi okužbami.
The CommissionŐs mandate for action is more clearly defined for veterinary and food related issues (paragraphs 14 to 16). 
Pooblastilo Komisije za ukrepanje je jasneje določeno pri zadevah na področjih veterinarske medicine in hrane (odstavki 14 do 16).
64 We examined whether the Commission and relevant EU agencies managed well key activities and resources to support Member States and EU funded research aimed at fighting AMR (paragraphs 18 and 19). 
64 Sodišče je preučilo, ali so Komisija in relevantne agencije EU dobro upravljale ključne dejavnosti in vire za podporo držav članic in raziskav, ki jih financira EU in so usmerjene v boj zoper protimikrobno odpornost (odstavka 18 in 19).
65 We conclude that the activities of the Commission and agencies have led to some progress, for example, in veterinary and food related issues. 
65 Sodišče zaključuje, da so dejavnosti Komisije in agencij prinesle nekaj napredka, na primer pri zadevah, povezanih z veterinarsko medicino in hrano.
However, there is little evidence to date that the health burden of AMR has been reduced in the European Union. 
Vendar je doslej malo dokazov, da je bilo zdravstveno breme, ki ga povzroča protimikrobna odpornost, v Evropski uniji zmanjšano.
66 We found that the Commission and ECDC support to strengthen Member StatesŐ One Health approach to AMR, while appreciated by the Member States and having the potential to provide a positive impact, has not yet delivered demonstrable results in reducing AMR. 
66 Sodišče je ugotovilo, da so države članice sicer cenile podporo, ki sta jim jo nudila Komisija in ECDC za okrepitev njihovega pristopa k protimikrobni odpornosti po načelu „eno zdravje”, in da bi ta podpora lahko imela pozitiven učinek, vendar še ni prinesla dokazljivih rezultatov pri zmanjšanju protimikrobne odpornosti.
We found that the EU funded Joint Action on antimicrobial resistance (JAMRAI) facilitated cooperation between Member States but faced challenges, particularly to the sustainable implementation of its results in the Member States (paragraph 23 and 24). 
Sodišče je ugotovilo, da je skupni ukrep EU na področju protimikrobne odpornosti (JAMRAI) omogočil lažje sodelovanje med državami članicami, vendar se pri njem pojavljajo izzivi, zlasti za trajnostno izvajanje njegovih rezultatov v državah članicah (odstavka 23 in 24).
An EU funded and OECD led project demonstrated that there was a range of relatively simple, cheap and cost effective options (antibiotic stewardship programmes, infection prevention and control measures, media campaigns and the use of rapid diagnostic tests) to reduce AMR in hospitals and other healthcare settings. 
Projekt, ki ga financira EU in vodi OECD, je pokazal, da obstaja vrsta razmeroma enostavnih, poceni in stroškovno učinkovitih možnosti (programi usmerjanja uporabe antibiotikov, ukrepi za preprečevanje in obvladovanje okužb, medijske kampanje in uporaba hitrih diagnostičnih testov) za zmanjšanje protimikrobne odpornosti v bolnišnicah in drugih zdravstvenih okoljih.
We consider that further synergies are available to support the fight against AMR by targeted, cost-effective investments co-financed with EU support in those Member States that need to take more incisive action (paragraphs 26 and 27). 36 
Sodišče meni, da so dosegljive dodatne sinergije za podpiranje boja zoper protimikrobno odpornost s ciljno usmerjenimi, stroškovno učinkovitimi naložbami, ki se sofinancirajo s podporo EU, v tistih državah članicah, ki morajo sprejeti odločnejše ukrepe (odstavka 26 in 27). 36
67 We found that overall, ECDC activities facilitate informed policy decisions (paragraphs 28 to 30). 
67 Sodišče je ugotovilo, da dejavnosti centra ECDC na splošno olajšujejo utemeljene odločitve o politikah (odstavki 28 do 30).